Clinical Trial Study of Hiv Case Report Form - Excel - Excel by mhy81963

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									                                         CPCRA IND studies, CRF Destruction March 2010


                                                                                                                Was
                                                                                                                protocol
                                                                                                                posted     IND Status
                                                                                       IND                      on the
  Network    Study Number                   Full Title                   Status                    IND Status              Change
                                                                                     Number                     list on    Date
                                                                                                                the RCC
                                                                                                                Website
                                                                                                                (Yes/No)
                            Prophylaxis Against Tuberculosis (TB) in
                            Patients with Human Immunodeficiency Closed to
CPCRA       CPCRA 004                                                               37,315    Inactive          Yes        N/A
                            Virus (HIV) Infection and Confirmed      Follow Up
                            Latent Tuberculous Infection


                            Prophylaxis Against Tuberculosis (TB) in
                            Patients with Human Immunodeficiency Closed to
CPCRA       CPCRA 005                                                               37,315    Inactive          Yes        N/A
                            Virus (HIV) Infection and Suspected      Follow Up
                            Latent Tuberculous Infection

                            A Randomized, Comparative, Placebo-
                            Controlled Trial of the Safety & Efficacy
                            of Oral Ganciclovir for Prophylaxis of
                                                                      Closed to
CPCRA       CPCRA 023       Cytomegalovirus (CMV) Retinal and                       41,649    Inactive          Yes        N/A
                                                                      Follow Up
                            Gastrointestinal Mucosal Disease in HIV-
                            Infected Individuals with Severe
                            Immunosuppression

                            A Prospective Study of Multidrug
                            Resistance and a Pilot Study of the
                            Safety of and Clinical and Microbiologic
                            Response to Levofloxacin in
CPCRA       CPCRA 026                                                  Terminated   42,796    Inactive          Yes        N/A
                            Combination With Other
                            Antimycobacterial Drugs for Treatment
                            of Multidrug-Resistant Pulmonary
                            Tuberculosis in HIV




                                                                  1
                                        CPCRA IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
                                                                                                            posted     IND Status
                                                                                   IND                      on the
  Network    Study Number                 Full Title                  Status                   IND Status              Change
                                                                                 Number                     list on    Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                            A Randomized, Double-Blind, Placebo-
                            Controlled Trial of Prophylaxis for
                            Disseminated MAC Disease and
                                                                    Closed to
CPCRA       CPCRA 048       Bacterial Pneumonia vs. Deferred                    53,552    Inactive          Yes        N/A
                                                                    Follow Up
                            Prophylaxis in HIV-Infected Pts Who
                            Experience Rebound in CD4+ Cell
                            Count Due to Active AR Therapy

                            A Prospective, Randomized, Open-
                            Label, Comparative Trial of
                            Dideoxyinosine (ddI) Versus             Closed to
CPCRA       CPCRA 002                                                           35,629    Withdrawn         Yes        N/A
                            Dideoxycytidine (ddC) in HIV-Infected   Follow Up
                            Patients Who are Intolerant of or Who
                            Have Failed Zidovudine (ZDV) Therapy

                            A Randomized, Comparative,
                            Prospective Study of Daily
                                                                  Closed to
CPCRA       CPCRA 006       Trimethoprim/Sulfamethoxazole (TMS)                 32,622    Withdrawn         Yes        N/A
                                                                  Follow Up
                            and Thrice-Weekly TMS for Prophylaxis
                            Against PCP in HIV-Infected Patients

                            A Randomized, Comparative Trial of
                                                                    Closed to
CPCRA       CPCRA 007       ZDV Versus ZDV Plus ddI Versus ZDV                  38,265    Withdrawn         Yes        N/A
                                                                    Follow Up
                            Plus ddC in HIV-Infected Patients




                                                               2
                                         CPCRA IND studies, CRF Destruction March 2010


                                                                                                              Was
                                                                                                              protocol
                                                                                                              posted     IND Status
                                                                                      IND                     on the
  Network    Study Number                  Full Title                    Status                  IND Status              Change
                                                                                    Number                    list on    Date
                                                                                                              the RCC
                                                                                                              Website
                                                                                                              (Yes/No)
                            A Prospective, Randomized,
                            Comparative Study of the Safety &
                            Efficacy of Clarithromycin vs Rifabutin vs
                                                                       Closed to
CPCRA       CPCRA 009       the Comb of Clarithromycin + Rifabutin                 41,373    Withdrawn        Yes        N/A
                                                                       Follow Up
                            for the Prevention of MAC Bacteremia or
                            Disseminated MAC Disease in HIV-
                            Infected Pts with CD4 < 100 cells/mm3

                            A Randomized, Comparative,
                            Prospective Study of Monthly
                            Aerosolized Pentamidine and Thrice
CPCRA       CPCRA 013       Weekly Dapsone for Prophylaxis Against Terminated      32,622    Withdrawn        Yes        N/A
                            PCP in HIV-Infected Patients Who are
                            Intolerant to Trimethoprim and/or
                            Sulfonamides

                            A Prospective Evaluation of the
                            Emergence of Resistance to Mono- and
                                                                     Closed to
CPCRA       CPCRA 014       Combination Therapy in Patients with                   38,265    Withdrawn        Yes        N/A
                                                                     Follow Up
                            </= 3 Months of Prior Therapy: A Blinded
                            Substudy of CPCRA 007

                            The Treatment of Pulmonary
                                                                      Closed to
CPCRA       CPCRA 019       Mycobacterium Tuberculosis in HIV                      41,372    Withdrawn        Yes        N/A
                                                                      Follow Up
                            Infection




                                                                  3
                                        CPCRA IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
                                                                                                           posted     IND Status
                                                                                   IND                     on the
  Network    Study Number                  Full Title                 Status                  IND Status              Change
                                                                                 Number                    list on    Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                            The Efficacy of a Standardized
                            Acupuncture Regimen and Amitriptyline
                                                                  Closed to
CPCRA       CPCRA 022       Compared with Placebo as a Treatment                41,279    Withdrawn        Yes        N/A
                                                                  Follow Up
                            for Pain Caused by Peripheral
                            Neuropathy in HIV-Infected Patients

                            An Open-Label, Randomized Trial of
                            Four Treatment Regimens for Patients
CPCRA       CPCRA 027       With Disseminated Mycobacterium        Terminated   43,458    Withdrawn        Yes        N/A
                            Avium Complex Disease and Acquired
                            Immunodeficiency Syndrome (AIDS)

                            A Study to Assess the Effect of
                            Concomitant Administration of          Closed to
CPCRA       CPCRA 030                                                           43,402    Withdrawn        Yes        N/A
                            Fluconazole on the Clinical            Follow Up
                            Pharmacokinetics of Methadone

                            A Randomized, Comparative Study of
                            Daily Dapsone and Daily Atovaquone for
                                                                    Closed to
CPCRA       CPCRA 034       Prophylaxis Against PCP in HIV-Infected             45,799    Withdrawn        Yes        N/A
                                                                    Follow Up
                            Patients Who are Intolerant of
                            Trimethoprim and/or Sulfonamides




                                                               4
                                        CPCRA IND studies, CRF Destruction March 2010


                                                                                                                Was
                                                                                                                protocol
                                                                                                                posted     IND Status
                                                                                       IND                      on the
  Network    Study Number                  Full Title                    Status                    IND Status              Change
                                                                                     Number                     list on    Date
                                                                                                                the RCC
                                                                                                                Website
                                                                                                                (Yes/No)
                            A Randomized Prospective, Double-
                            Blind Study Comparing Fluconazole with
                                                                   Closed to
CPCRA       CPCRA 010       Placebo for Primary and Secondary                       37,701    Inactive          Yes        N/A
                                                                   Follow Up
                            Prophylaxis of Mucosal Candidiasis in
                            HIV-Infected Women

                            Oral Etoposide for the Treatment of
CPCRA       CPCRA 025                                                  Withdrawn    34,080    Withdrawn         Yes        N/A
                            Kaposi's Sarcoma in HIV+ Patients

                            A Prospective Substudy of Fungal
                            Resistance in Women Participating in       Closed to
CPCRA       CPCRA 029                                                               37,701    Inactive          Yes        N/A
                            the Women's Fungal Prophylaxis             Follow Up
                            Protocol (CPCRA 010)

                            A Randomized Trial of Immediate
                            Versus Deferred Indinavir (IDV) in
                            Addition to Background Antiretroviral
CPCRA       CPCRA 041       Therapy in HIV-Infected Patients With      Terminated   49,458    Inactive          Yes        N/A
                            CD4+ Cell Counts Between 200-
                            500/mm3 and Plasma HIVRNA Levels
                            >= 10,000 Copies/mL.




                                                                   5
                                        CPCRA IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
                                                                                                             posted     IND Status
                                                                                    IND                      on the
  Network    Study Number                  Full Title                  Status                   IND Status              Change
                                                                                  Number                     list on    Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                            CPCRA 042/CTN102A Randomized
                            Trial of the Efficacy and Safety of a
                            Strategy of Starting WIth Nelfinavir
                            Versus Ritonavir Added to Background     Closed to
CPCRA       CPCRA 042                                                            51,909    Inactive          Yes        N/A
                            Antiretroviral Reverse Transcriptase     Follow Up
                            Inhibitor Therapy in HIV-Infected
                            Individuals With CD4+ Cell Counts
                            <=200/mm3

                            A Prospective Evaluation of HIV-1
                            Genotypic Resistance to Nelfinavir and
                                                                     Closed to
CPCRA       CPCRA 045       Ritonavir, and Viral Load in Patients                51,909    Inactive          Yes        N/A
                                                                     Follow Up
                            With <100 CD4+ Cell Counts: A
                            substudy of CPCRA 042

                            Effects of Prophylaxis for Disseminated
                            Mycobacterium avium Complex (MAC)
                            Disease With Azithromycin vs. Deferred
                                                                    Closed to
CPCRA       CPCRA 054       Prophylaxis on Carriage of Antibiotic-               53,552    Inactive          Yes        N/A
                                                                    Follow Up
                            Resistant Streptococcus pneumoniae: A
                            Substudy of the CR-MAC Protocol
                            (CPCRA 048)




                                                                 6
                                        CPCRA IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
                                                                                                            posted     IND Status
                                                                                   IND                      on the
  Network    Study Number                 Full Title                 Status                    IND Status              Change
                                                                                 Number                     list on    Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                            A Randomized Study of the Virologic
                            Efficacy of Different Antiretroviral (AR)
                            Treatment Strategies in HIV-Infected
CPCRA       CPCRA 057       Individuals With Detectable Plasma HIV Terminated   56,801    Inactive          Yes        N/A
                            RNA Measurements After At Least 16
                            Weeks on Their Initial Protease Inihibitor-
                            Containing AR Regimens

                            Immediate Combination Nucleoside
                            Therapy Versus Zidovudine Followed by
CPCRA       CPCRA 015                                             Withdrawn     38,265    Withdrawn         Yes        N/A
                            Delayed Combination Therapy in
                            Patients with HIV Infection




                                                              7
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                             Full Title                     Status   IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)

                     T-Lymphocyte Synthesis in HIV Infected
                     Subjects Following > 96 Weeks of Potent
AACTG      A5002s                                                Concluded   57,975         Inactive       Yes           N/A
                     Antiretroviral Therapy: A Nested Study of
                     ACTG 375


                     A Randomized, Open-Label, Pilot
                     Treatment Trial Evaluating Cellular
                     Dynamics and Immune Restoration in
AACTG      A5014     Treatment Naive HIV-Infected Subjects       Concluded   59,306         Inactive       Yes           N/A
                     Receiving the Protease Inhibitor LPV or the
                     Nucleoside Analogue Reverse
                     Transcriptase Inhibitors d4T/3TC/ABC

                     A Phase II Randomized Study of the Safety
                     and Efficacy of Hydroxyurea in Patients on
AACTG      A5025     Potent Antiretroviral Therapy with Less    Concluded    58,979         Withdrawn      Yes           N/A
                     than 200 Copies/mL of HIV RNA in the
                     Plasma




                     A5026s is a Substudy of A5025:
AACTG      A5026s                                                Concluded   58,979         Withdrawn      Yes           N/A
                     Immunology Substudy




                                                                    8
                                            ACTG IND studies, CRF Destruction March 2010


                                                                                                          Was
                                                                                                          protocol
             Study                                                                                        posted on     IND Status
 Network                             Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                      Change Date
                                                                                                          the RCC
                                                                                                          Website
                                                                                                          (Yes/No)


                     Phase II Randomized, Open-Label, Pilot
                     Study of Maintenance of HIV RNA
AACTG      A5039     Suppression After Switching to ddI/d4T/HU Concluded    58,159         Inactive       Yes           N/A
                     vs. ddI/d4T/EFZ vs. Continuing the Pre-
                     Entry Protease Inhibitor Regimen


                     The Effects of GM-CSF on HIV-1 RNA and
                     Chemokine Receptor Expression in HIV-1
AACTG      A5041                                            Concluded       BB8588         Inactive       Yes           N/A
                     Infected Subjects Receiving Potent
                     Antiretroviral Therapy

                     A Controlled, Pilot Study of the
                     Immugenicity of RemuneTM in HIV-
                     Infected Subjects Receiving Either Highly
AACTG      A5046s                                               Concluded   BB8318         Withdrawn      Yes           N/A
                     Active Antiretroviral Therapy (HAART)
                     Alone or HAART and Interleukin-2 (IL-2): A
                     Nested Substudy of ACTG 328

                     Evaluation of Potential Pharmacokinetic
AACTG      A5047     Interactions Between Protease Inhibitors   Concluded   58,175         Withdrawn      Yes           N/A
                     and Lipid Lowering Agents




                                                                   9
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                    Status    IND Number       IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                     A Phase I, Multicenter, Open -Label,
                     Sequential Cohort Trial of HIV Vaccine
                     (Polyvalent Peptide Vaccine C4-V3) in
AACTG      A5049                                                 Concluded    BB8547          Inactive       Yes           N/A
                     Conjunction with Interleukin-12 in Subjects
                     with Maximal Suppression of HIV
                     Replication and CD4 Count>400 cells/mm3


                     A Phase II, Restrictively Randomized,
AACTG      A5061     Open-Label, Pilot Study of Treatment         Concluded   58,975          Inactive       Yes           N/A
                     Intensification in Early Virologic Failure

                     The Effect of Addition of Delayed Versus
                     Immediate HU to a ddI-Containg Genotypic
                     - Based Regimen (>=3drugs) in HIV-
AACTG      A5069     Infected Subjects Failing 1 or 2nd Triple Withdrawn      49,928          Inactive       Yes           N/A
                     Combination Therapy on the Recovery of
                     Total CD4 Cell Counts & Viral Load
                     Suppression

                     A Prospective, Multicenter, Randomized
                     Trial Comparing the Efficacy and Safety of
AACTG      A5087                                                POS PAC       60,939          Inactive       Yes           N/A
                     Fenofibrate versus Pravastatin in HIV-
                     Infected Subjects with Lipid Abnormalities




                                                                    10
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                    Status    IND Number       IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                     A Phase I/II Study of the Safety ,
                     Tolerability, and Antiretroviral Activity of
                     Mycophenolate Mofetil as an Adjunct to
AACTG      A5105                                                  Withdrawn   62,737          Inactive       Yes           N/A
                     Abacavir Therapy in HIV-Infected Subjects
                     with Treatment Failure and Extensive Prior
                     Antiretroviral Exposure

                     A Randomized Phase I/II Placebo -
                     Controlled Study of Amdoxovir (DAPD) vs.
                     Placebo together with Enfuvirtide (T-20)
AACTG      A5118                                              Concluded       63,754          Inactive       Yes           N/A
                     Plus Optimized Background Therapy for
                     HIV Infected Subjects Failing Current
                     Therapy

                     A Substudy of A5105: Intensive
                     Pharmacokinetic Study of Mycophenolic
                     Acid (MPA) and Evaluation of Carbovir
AACTG      A5121s                                                 Withdrawn   62,737          Inactive       Yes           N/A
                     Triphosphate (CBV-TP) and
                     Deoxyguanosine Triphosphate (dGTP)
                     Levels

                     Evaluation of Potential Pharmacokinetic
AACTG      A5159     Interactions Between HIV Protease            Concluded   64,874          Inactive       Yes           N/A
                     Inhibitors and Calcium Channel Blockers

                     Multicenter, Pilot Study of Telbivudine
                     (LdT) Anti-HBV Treatment Prior to the
AACTG      A5167     Initiation of Highly Active Antiretroviral   Withdrawn   66,388          Inactive       Yes           N/A
                     Therapy Containing Lamivudine in
                     Subjects CoInfected with HBV and HIV



                                                                    11
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status    IND Number      IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)


                      A Placebo-Controlled Trial to Evaluate AZT
                      in the Treatment of HIV Infection in
AACTG      ACTG 001                                              Concluded    28,972        Inactive       Yes           N/A
                      Patients with AIDS-Associated Kaposi's
                      Sarcoma



                      A Multi-Center Clinical Trial to Evaluate
AACTG      ACTG 002   AZT in the Treatment of HIV Infection in  Concluded     28,972        Inactive       Yes           N/A
                      Patients with AIDS post First Episode PCP

                      Phase I Studies of the Combination of AZT
AACTG      ACTG 004   and DHPG in Patients with AIDS and CMV Concluded        28,972        Inactive       Yes           N/A
                      Infection

                      A Multicenter Placebo-Controlled Double-
                      Blind Trial to Evaluate AZT Treatment of
AACTG      ACTG 005                                            Concluded      28,972        Inactive       Yes           N/A
                      the AIDS Dementia Complex and CNS HIV
                      Infection


                      The Safety and Efficacy of AZT in the
AACTG      ACTG 016                                             Concluded     28,972        Inactive       Yes           N/A
                      Treatment of Patients with Early ARC


                      A Phase I Trial to Evaluate AZT in the
AACTG      ACTG 017   Treatment of HIV Infection in Patients with Concluded   28,972        Inactive       Yes           N/A
                      Hemophilia



                                                                   12
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      Safety and Efficacy of Zidovudine for
AACTG      ACTG 019                                              Concluded   28,972         Inactive       Yes           N/A
                      Asymptomatic HIV Infected Individuals


                      A Multicenter, Uncontrolled Trial to
                      Evaluate the Long Term Safety and
AACTG      ACTG 020   Tolerance of AZT in the Treatment of HIV   Concluded   28,972         Inactive       Yes           N/A
                      Infection in Patients with AIDS and
                      Advanced ARC

                      Influence of Probenecid and Quinine on
AACTG      ACTG 027                                              Concluded   28,972         Inactive       Yes           N/A
                      the Pharmacokinetics of AZT



                      Evaluation of the Interaction Between
AACTG      ACTG 032                                              Concluded   28,972         Inactive       Yes           N/A
                      Acetaminophen and AZT



                      Evaluation of the Interaction Between Low
AACTG      ACTG 033                                             Concluded    28,972         Inactive       Yes           N/A
                      Dose TMP/SMX and AZT


                      A Placebo Controlled Trial to Evaluate AZT
AACTG      ACTG 036   in the Treatment of HIV Infection in       Concluded   28,972         Inactive       Yes           N/A
                      Hemophilic Patients




                                                                   13
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      Evaluation of the Interaction Between High
AACTG      ACTG 037                                              Concluded   28,972          Inactive       Yes           N/A
                      Dose TMP/SMX and AZT

                      Open Label Phase I Study to Evaluate the
                      Safety of Combination Therapy with AZT
AACTG      ACTG 057                                             Concluded    BB3100          Inactive       Yes           N/A
                      and Recombinant IFN-Beta in Patients with
                      AIDS-Related Kaposi's Sarcoma

                      An Open Trial of AZT Treatment of the
AACTG      ACTG 061   AIDS Dementia Complex in Patients with     Concluded   28,972          Inactive       Yes           N/A
                      AIDS or Low CD4+ Lymphocyte Counts

                      A Clinical Study Examining the
                      Pharmacokinetics and Bioavailability of
AACTG      ACTG 062                                              Concluded   28,972          Inactive       Yes           N/A
                      AZT in Patients with HIV Infection and
                      Hepatic Disease

                      A Phase I Safety, Efficacy and
AACTG      ACTG 064   Pharmacokinetic Study of ddI Administered Concluded    31,945          Withdrawn      Yes           N/A
                      Twice Daily to Patients with AIDS or ARC

                      A Phase I Study of Autologous, Activated
                      CD8(+) Lymphocytes Expanded In Vitro
AACTG      ACTG 080                                              Concluded   BB3337          Inactive       Yes           N/A
                      and Infused With or Without rIL-2 To
                      Patients With AIDS or Severe ARC




                                                                   14
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status    IND Number      IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      Pilot Study to Determine the Feasibility of
                      Itraconazole for Suppression of Relapse of
AACTG      ACTG 084   Disseminated Histoplasmosis in Patients     Concluded   33,047        Withdrawn      Yes           N/A
                      with Acquired Immune Deficiency
                      Syndrome


                      A Randomized, Placebo-Controlled Trial of
AACTG      ACTG 087   Azidothymidine in Patients with HIV-related Withdrawn   28,972        Inactive       Yes           N/A
                      Auto-Immune Thrombocytopenic Purpura


                      Evaluation of Zidovudine Pharmacokinetics
                      in Patients with Human Immunodeficiency
AACTG      ACTG 088                                             Withdrawn     28,972        Inactive       Yes           N/A
                      Virus and on Continuous Ambulatory
                      Peritoneal Dialysis (CAPD)

                      A Phase I Trial of Recombinant Human
                      Granulocyte-Macrophage Colony
                      Stimulating Factor (rHuGM-CSF),
AACTG      ACTG 090                                             Concluded     BB3038        Inactive       Yes           N/A
                      Recombinant Alpha Interferon and
                      Azidothymidine (AZT) in AIDS-Associated
                      Kaposi's Sarcoma


                      Evaluation of Drug Interactions Between
AACTG      ACTG 104                                             Withdrawn     28,972        Inactive       Yes           N/A
                      Zidovudine (ZDV), Aspirin and Ibuprofen




                                                                   15
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                      Status   IND Number      IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                      Safety and Tolerance of Zidovudine with
                      Probenecid and the Effect of Probenecid in
AACTG      ACTG 107                                              Concluded      28,972        Inactive       Yes           N/A
                      Zidovudine Pharmacokinetics Over Four
                      Weeks



                      Phase I Study of Weekly Oral VP-16 for
AACTG      ACTG 110                                                 Concluded   34,080        Inactive       Yes           N/A
                      AIDS Associated Kaposi's Sarcoma



                      Pilot Study to Determine the Feasibility of
                      Itraconazole for Primary Treatment and
                      Suppression of Relapse of Disseminated
AACTG      ACTG 120                                                 Concluded   33,047        Withdrawn      Yes           N/A
                      Histoplasmosis in Patients with the
                      Acquired Immunodeficiency Syndrome
                      (AIDS)

                      A Phase I Pharmacokinetic and Tolerance
AACTG      ACTG 127   Study of 28-Day Regimens of Oral        Concluded         28,972        Inactive       Yes           N/A
                      Ganciclovir

                      Comparison of 2',3'-Dideoxyinosine (ddI)
                      and Zidovudine (ZDV) in Therapy of
AACTG      ACTG 140                                            Concluded        35,208        Withdrawn      Yes           N/A
                      Patients with the AIDS Dementia Complex
                      (ADC)




                                                                      16
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status    IND Number      IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Phase I/II, Open Label Study to Evaluate
                      the Antiviral Potential of Combination
AACTG      ACTG 143   Zidovudine and 2'3'-Dideoxyinosine         Concluded    35,208        Withdrawn      Yes           N/A
                      (Didanosine) in Patients With
                      Asymptomatic HIV Disease

                      A Randomized Double Blind Protocol
                      Comparing Amphotericin B with
                      Flucytosine to Amphotericin B Alone
AACTG      ACTG 159                                              Concluded    37,434        Withdrawn      Yes           N/A
                      Followed by a Comparison of Fluconazole
                      and Itraconazole in the Treatment of Acute
                      Cryptococcal Meningitis

                      Randomized, Double-Blinded, Placebo-
                      Controlled Trial of Nimodipine for the
AACTG      ACTG 162                                            Concluded      37,839        Withdrawn      Yes           N/A
                      Neurological Manifestations of HIV-1 as
                      Concurrent Therapy with Zidovudine (ZDV)
                      Prophylaxis Against Tuberculosis (TB) in
                      Patients with Human Immunodeficiency
AACTG      ACTG 177                                              Concluded    37,315        Inactive       Yes           N/A
                      Virus (HIV) and Confirmed Latent
                      Tuberculosis Infection
                      A Randomized Comparative Phase I Study
                      of Oral Ganciclovir After Treatment with IV
AACTG      ACTG 183                                               Concluded   41,649        Inactive       Yes           N/A
                      Ganciclovir for Cytomegalovirus
                      Gastrointestinal Disease in AIDS Patients




                                                                   17
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
              Study                                                                                          posted on     IND Status
 Network                                Full Title                     Status   IND Number      IND Status   the list on
             Number                                                                                                        Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                     A Randomized, Double-Blind, Four-Arm
                     Study Comparing Combination Nucleoside,
AACTG      ACTG 193A Alternating Nucleoside, and Triple Drug Concluded          42,003        Inactive       Yes           N/A
                     Therapy for the Treatment of Advanced
                     HIV Disease (CD4</=50)

                       A Study to Evaluate the Short-Term
AACTG      ACTG 194    Clinical and Virologic Significance of AZT   Concluded   35,208        Withdrawn      Yes           N/A
                       Resistance

                       A Phase III, Randomized Trial of Topical
                       Vaginal Fluorouracil (5-Fluorouracil, 5-FU)
AACTG      ACTG 200    Maintenance Therapy vs. Observation         Concluded    40,765        Withdrawn      Yes           N/A
                       After Standard Treatment for High Grade
                       Cervical Dysplasia in HIV-Infected Women




AACTG      ACTG 202    Dexamethasone in Cryptococcal Meningitis Concluded       41,525        Inactive       Yes           N/A



                       A Randomized Phase II Trial to Determine
                       the Safety, Tolerance and Efficacy of Two
AACTG      ACTG 206    Doses of Interferon Alpha Combined with Concluded        34,595        Withdrawn      Yes           N/A
                       Didanosine in Patients with Kaposi's
                       Sarcoma




                                                                      18
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      A Phase I Study of TNP-470 in the
AACTG      ACTG 215   Treatment of AIDS-Associated Kaposi's      Concluded   41,244          Withdrawn      Yes           N/A
                      Sarcoma
                      Chemoprevention of Anal Neoplasia
                      Arising Secondary to Anogenital Human
AACTG      ACTG 216                                              Concluded   41,357          Withdrawn      Yes           N/A
                      Papillomavirus Infection in Persons with
                      HIV Infection

                      A Phase II/III Prospective, Multicenter,
                      Randomized, Controlled Trial Comparing
                      the Safety and Efficacy of Three
AACTG      ACTG 223   Clarithromycin-Containing Combination      Concluded   43,856          Inactive       Yes           N/A
                      Drug Regimens for the Treatment of
                      Disseminated MAC Disease in Persons
                      with AIDS

                      A Phase I Open-Label Study of the Safety,
                      Tolerance, and Pharmacokinetic
AACTG      ACTG 231                                             Concluded    41,826          Withdrawn      Yes           N/A
                      Interactions of Combination Didanosine
                      and Ribavirin in HIV-Positive Individuals


                      A Prospective Study of Multidrug
                      Resistance and a Pilot Study of the Safety
                      of and Clinical and Microbiologic Response
AACTG      ACTG 238                                              Concluded   42,796          Inactive       Yes           N/A
                      to Levofloxacin in Combination with Other
                      Antimycobacterial Drugs for Treatment of
                      MDRTB in HIV-Infected Patients




                                                                   19
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Comparative Study of a Combination of
                      Zidovudine, Didanosine, and Nevirapine
AACTG      ACTG 241                                              Concluded   42,003         Inactive       Yes           N/A
                      Versus a Combination of Zidovudine and
                      Didanosine

                      A Phase II Multicenter Study Comparing
                      Antiretroviral Therapy Alone to
                      Antiretroviral Therapy plus Cytosine
AACTG      ACTG 243   Arabinoside for the Treatment of         Concluded     44,084         Inactive       Yes           N/A
                      Progressive Multifocal
                      Leukoencephalopathy (PML) in Human
                      Immunodeficiency Virus Infected Subjects

                      A Double-Blind, Randomized Trial
                      Comparing ZDV, ZDV + ddI, and ZDV +
                      ddI + NVP in Asymptomatic Patients on
AACTG      ACTG 244   ZDV Monotherapy Who Develop a              Concluded   42,003         Inactive       Yes           N/A
                      Mutation at Codon 215 of HIV Reverse
                      Transcriptase in Plasma Associated Viral
                      RNA



                      Thalidomide for Treatment of Oral and
AACTG      ACTG 251   Esophageal Aphthous Ulcers and HIV         Concluded   43,791         Inactive       Yes           N/A
                      Viremia in Patients with HIV Infection




                                                                   20
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                     Status   IND Number       IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)

                      Methadone Effects on Zidovudine (ZDV,
AACTG      ACTG 262                                                Concluded   28,972         Inactive       Yes           N/A
                      AZT) Disposition


                      Phase II Evaluation of Low-Dose Oral
                      Etoposide for the Treatment of Relapsed
AACTG      ACTG 269                                                Concluded   34,080         Inactive       Yes           N/A
                      or Progressed AIDS-Related Kaposi's
                      Sarcoma After Systemic Chemotherapy

                      A Phase II Randomized, Double-Blind,
                      Placebo Controlled Trial of the Virologic
                      Effect of Two Different Nucleoside
AACTG      ACTG 275   Treatment Strategies (ZDV vs ZDV in          Concluded   35,208         Withdrawn      Yes           N/A
                      combination with ddI) for HIV Infection in
                      Subjects with CD4+ Counts > or =
                      550/mm3

                      A Multicenter Phase II Double-Blind Study
                      to Evaluate     Differences Among Various
AACTG      ACTG 276   ZDV/ddI Regimens on Quantitative          POS PAC        35,208         Withdrawn      Yes           N/A
                      Measures of Viral Burden in Relatively
                      Early HIV-1 Infection

                      A Study of a Fixed-Schedule Regimen of
                      Alternating Oral and Intravenous
AACTG      ACTG 278                                                Concluded   41,649         Withdrawn      Yes           N/A
                      Ganciclovir for Treatment of
                      Cytomegalovirus Retinitis




                                                                     21
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                     Status   IND Number      IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      Effect of Fluconazole, Clarithromycin, and
                      Rifabutin on the Pharmacokinetics of
AACTG      ACTG 283                                              Concluded     47,840        Withdrawn      Yes           N/A
                      Sulfamethoxazole and Dapsone and Their
                      Hydroxylamine Metabolites

                      Comparison Study of Liposomal
                      Doxorubicin With or Without Bleomycin
AACTG      ACTG 286   and Vincristine for the Treatment of         Concluded   47,241        Withdrawn      Yes           N/A
                      Advanced AIDS-Associated Kaposi's
                      Sarcoma

                      A Randomized Phase III Trial of Oral
                      Isotretinoin vs. Observation for Low Grade
AACTG      ACTG 293                                              Concluded     41,357        Withdrawn      Yes           N/A
                      Squamous Intraepithelial Lesions in HIV
                      Infected Women

                      A Phase I/II Dosing Study of the Safety and
                      Antiretroviral Activity of Hydroxyurea Alone
AACTG      ACTG 307                                                POS PAC     49,928        Inactive       Yes           N/A
                      and in Combination with ddI Compared
                      with ddI Alone

                      A Randomized, Double-Blind, Placebo-
                      Controlled, Phase I/II Trial of Nandrolone
AACTG      ACTG 329                                              Concluded     51,571        Withdrawn      Yes           N/A
                      Decanoate in Women with HIV-Associated
                      Weight Loss

                      Phase II Study of Cyclosporine (Neoral) in
AACTG      ACTG 334   Immune Activation and HIV Expression in      Concluded   52,207        Inactive       Yes           N/A
                      Early HIV Disease




                                                                     22
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                     Status   IND Number       IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                      Pathogenesis of MAC Disease in
                      Advanced HIV-1-Infected Subjects and the
                      Impact of Highly-Active Antiretroviral
AACTG      ACTG 341                                            Concluded       54,432         Inactive       Yes           N/A
                      Therapy (HAART) on Immune Functions
                      Relevant for MAC and Opportunistic
                      Infections (OIs)

                      Activity of the Soft Gelatin Capsule of SQV
                      in Combination with RTV or Nelfinavir and
                      Combinations of DLV, and/or Adefovir
AACTG      ACTG 359                                                 POS PAC    53,549         Inactive       Yes           N/A
                      Dipivoxil in HIV Infected Subjects with Prior
                      IDV use and Viral Loads of >/= 2,000 and
                      </= 200,000 copies HIV RNA/mL.

                      Pilot Study on the Effect of Cidofovir For
                      the Treatment of Progressive Multifocal
AACTG      ACTG 363   Leukoencephalopathy (PML) in Patients        Concluded   53,534         Inactive       Yes           N/A
                      with the Acquired Immunodeficiency
                      Syndrome (AIDS)


                      Steady-State Pharmacokinetic Interaction
AACTG      ACTG 365                                                Concluded   53,368         Inactive       Yes           N/A
                      Study of Indinavir and Rifabutin




                                                                     23
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status    IND Number      IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Phase II Study of the Prolongation of
                      Virologic Success (ACTG 371A) and
                      Options for Vir. Failure (ACTG 372 B/C/D)
AACTG      ACTG 372                                             POS PAC       53,844        Inactive       Yes           N/A
                      in HIV-Infected Subj. Receiving IDVin
                      Comb. with Nucleoside Analogs: A
                      Rollover Study for ACTG 320

                      A Phase II Study of 1) Amprenavir
                      (141W94/VX-478) plus 3TC plus ZDV (or
                      d4T); 2) Indinavir Plus Nevirapine plus 3TC
AACTG      ACTG 373                                               Concluded   53,774        Inactive       Yes           N/A
                      plus Stavudine or 3) Other Treatment
                      Regimens in Subjects Previously Treated
                      with Amprenavir (141W94/VX-478)


                      Immunologic and Virologic Consequences
                      of Long-Term Highly Active Antiretroviral
AACTG      ACTG 375   Therapy (HAART) in Subjects with          POS PAC       BB7288        Inactive       Yes           N/A
                      Moderately Advanced, HIV-1 Disease: A
                      Follow-Up Study to ACTG 315

                      A Prototype Study to Test the Effect of
                      Staggered Dosing on the Pharmacokinetic
                      Interactions Between Paired Combinations
AACTG      ACTG 378                                             Concluded     53,549        Inactive       Yes           N/A
                      of Nelfinavir (NFV), Ritonavir (RTV), and
                      the Soft Gelatin Capsule of Saquinavir
                      (SQVsgc)




                                                                   24
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      Effect of Cytoreductive Chemotherapy
                      Combined with Aggressive Antiretroviral
AACTG      ACTG 380                                             Concluded   55,201          Inactive       Yes           N/A
                      Therapy on Lymph Node HIV DNA in HIV
                      Infected Subjects

                      Study of Protease Inhibitor and/or Non-
                      Nucleoside Reverse Transcriptase Inhibitor
AACTG      ACTG 384                                               POS PAC   56,836          Inactive       Yes           N/A
                      with Dual Nucleosides in Initial Therapy of
                      HIV Infection

                      A Phase III, Randomized, Controlled Trial
                      of Efavirenz (EFV) or Nelfinavir (NFV) in
                      Combination with Fixed-Dose Combination
AACTG      ACTG 388   Lamivudine/Zidovudine (3TC/ZDV) and       Concluded   55,707          Inactive       Yes           N/A
                      Indinavir (IDV) in HIV-Infected Subjects
                      with <=200 CD4 Cells/MM3 or >= 80,000
                      HIV RNA Copies/m

                      A Phase II, Rand Trial of APV as Pt of Dual
                      PI Regimens (Placebo Controlled) in Comb
                      w/ ABC, EFV & ADV vs. APV Alone in HIV
AACTG      ACTG 398   Infected Subjects w/Prior Expo. to Apprvd POS PAC     56,568          Inactive       Yes           N/A
                      PIs and Loss of Virologic Supp. as
                      Reflected By A Plasma HIV-1 RNA of >=
                      1000 copies/ml




                                                                  25
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                     Status    IND Number     IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      A Randomized, Open Label, Comparative
                      Trial of Salvage Antiretroviral Therapies for
AACTG      ACTG 400                                                 Concluded   56,820       Inactive       Yes           N/A
                      HIV-Infected Individuals with Virological
                      Evidence of Nelfinavir Treatment Failure

                      The Effect of HIV Protease Inhibitors on
AACTG      ACTG 401   the Stereospecific Metabolism of            Concluded     53,549       Inactive       Yes           N/A
                      Methadone in HIV Infected Subjects

                      ACTG 810 is a Micro-neuro Substudy of
AACTG      ACTG 810                                               Concluded     42,003       Inactive       Yes           N/A
                      ACTG 193A
                      ACTG 811 is a Macro-neuro Substudy of
AACTG      ACTG 811                                               Concluded     42,003       Inactive       Yes           N/A
                      193A
                      ACTG 812 is a Pharmacology Substudy of
AACTG      ACTG 812                                          Concluded          42,003       Inactive       Yes           N/A
                      193A


AACTG      ACTG 813   ACTG 813 is a Virology Substudy of 193A     Concluded     42,003       Inactive       Yes           N/A



                      ACTG 814 is a substudy of ACTG 251:
AACTG      ACTG 814                                               Concluded     43,791       Inactive       Yes           N/A
                      Pharmacokinetics Of Thalidomide




                                                                     26
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      ACTG 818, a Substudy of ACTG 238:
                      Pharmacokinetics Substudy of
AACTG      ACTG 818                                            Withdrawn     42,796         Inactive       Yes           N/A
                      Antituberculosis Agents in Patients
                      Enrolled in ACTG 238/CPCRA 026

                      Substudy of ACTG 223...Effect of Rifabutin
                      and Ethambutol on the Pharmacokinetics
                      of Clarithromycin in the Treatment of
AACTG      ACTG 823   Mycobacterium Avium Infection in Persons Concluded     43,856         Inactive       Yes           N/A
                      with HIV Infection: A Clinical
                      Pharmacology Substudy of ACTG Protocol
                      223

                      ACTG 824 Substudy of ACTG
                      223...Pharmacokinetics and
                      Pharmacodynamics of Clarithromycin,
AACTG      ACTG 824   Rifabutin, and Ethambutol in the Treatment Concluded   43,856         Inactive       Yes           N/A
                      of Mycobacterium avium Infection in
                      Persons with HIV Infection: A Clinical
                      Pharmacology Substudy of ACTG 223

                      ACTG 831 is a substudy of ACTG 251:
AACTG      ACTG 831   Collection of PBMC For Cytokine mRNA     Concluded     43,791         Inactive       Yes           N/A
                      Measurements


                      ACTG 832 is an Immunology Substudy of
AACTG      ACTG 832   ACTG 275: Lymphocyte Proliferation       Concluded     35,208         Withdrawn      Yes           N/A
                      Assay & Apoptotic Cell Death




                                                                  27
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                     Status    IND Number     IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      ACTG 833 is a Virology Substudy of ACTG
AACTG      ACTG 833                                           Withdrawn        35,208       Withdrawn      Yes           N/A
                      275: HIV Burden in Lymphoid Tissue
                      ACTG 839 is a substudy of ACTG 244
                      "Drug-Taking Behavior and Drug Exposure
AACTG      ACTG 839                                            Concluded       42,003       Inactive       Yes           N/A
                      as Correlates of Resistance and Response
                      to Antiretrovirals"
                      ACTG 842 is a substudy of ACTG 251:
                      The Prevalence of Idiopathic Genital Ulcer
AACTG      ACTG 842   Disease and Effect of Thalidomide          Concluded     43,791       Inactive       Yes           N/A
                      Treatment on Idiopathic Genital Ulcers
                      Among HIV Infected Women.

                      ACTG 851 is an Immunology Substudy of
                      ACTG 275: Cytokine and HIV RNA
AACTG      ACTG 851                                                Concluded   35,208       Withdrawn      Yes           N/A
                      expression in skin biopsies of subjects with
                      a positive DTH response

                      ACTG 854 is a Substudy of ACTG 276
                      "Intracellular Pharmacokinetics of
AACTG      ACTG 854   Zidovudine Triphosphate After Single and   Concluded     35,208       Withdrawn      Yes           N/A
                      Multiple Dose Administration of
                      Zidovudine"

                      ACTG 855 is a Substudy of ACTG 276,
                      "Phenotypic Immunologic Studies in Early
AACTG      ACTG 855   HIV-1 Infected Patients (CD4 >/= 550)    Concluded       35,208       Withdrawn      Yes           N/A
                      Receiving Combination Zidovudine and ddI
                      Therapy"




                                                                    28
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                     Status    IND Number     IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      ACTG 856 is a Substudy of ACTG 276
                      "Functional Immunologic Studies in Early
AACTG      ACTG 856   HIV-1 Infected Patients (CD4 >/= 550)    Concluded       35,208       Withdrawn      Yes           N/A
                      Receiving Combination Zidovudine and ddI
                      Therapy"
                      ACTG 858 is a substudy of ACTG 276
                      entitled "In vivo Dynamics of HIV-1 Prior to
                      the Initiation and Following the Cessation
AACTG      ACTG 858                                                Concluded   35,208       Withdrawn      Yes           N/A
                      of Various Regimens of ZDV and/or ddI in
                      Subjects with Relatively Early HIV-1
                      Infection

                      ACTG 865 is a Substudy of ACTG 223:
AACTG      ACTG 865                                              Concluded     43,856       Inactive       Yes           N/A
                      Use of PCR to Detect MAC Bacteremia


                      A Randomized Multi-Center Phase II Trial
AACTG      ACTG 025   of Recombinant TNF and Recombinant         Concluded     BB2679       Terminated     Yes           N/A
                      IFN-gamma in Patients with ARC

                      Active Immunization of Asymptomatic, HIV-
                      Infected Individuals with Recombinant HIV
AACTG      ACTG 137                                             Concluded      BB2775       Terminated     Yes           N/A
                      gp160 Antigen: A Phase I/II Study of
                      Immunogenicity and Toxicity




                                                                    29
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status    IND Number      IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Phase I/II Dose-Escalation Study of
                      Intradermal gp160 to Evaluate Safety, DTH
                      (Skin Test) Responses and
AACTG      ACTG 148                                             Concluded     BB2775        Terminated     Yes           N/A
                      Immunogenicity in Asymptomatic, HIV-
                      Seropositive Subjects with More Than 400
                      CD4 Cells

                      A Phase II Study of G-CSF Plus ABVD in
AACTG      ACTG 149   the Treatment of HIV-Associated Hodgkin's Concluded     BB4220        Terminated     Yes           N/A
                      Disease

                      A Phase I/II Trial of Vaccine Therapy of
AACTG      ACTG 209   HIV-1 Infected Individuals with 50-500 CD4 Concluded    BB4705        Terminated     Yes           N/A
                      Cells/mm3
                      A Phase I Comparative Blinded Trial of
                      Several HIV-1 DerivedImmunogens in
AACTG      ACTG 214                                              Concluded    BB5115        Terminated     Yes           N/A
                      Infected Individuals with >/= 500 CD4
                      Cells/mm3
                      A Pilot Study of Stem Cell Mobilization and
AACTG      ACTG 285   Harvesting from the Peripheral Blood        Concluded   BB4220        Terminated     Yes           N/A
                      Using G-CSF

                      A Phase I, Double-Blind Trial of
                      Recombinant Human Interleukin-12 (rhIL-
AACTG      ACTG 325   12) in HIV-Infected Subjects With Less    Concluded     BB6777        Terminated     Yes           N/A
                      Than 50 CD4+ T Cells and Subjects with
                      300-500 CD4+ T Cells




                                                                   30
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                     Status    IND Number     IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Multicenter, Randomized Controlled Trial
                      to Compare the Efficacy of a Four Drug
                      Antiretroviral Regimen Alone or in
AACTG      ACTG 387   Combination with GM-CSF or IL-12            Concluded    BB7436       Terminated     Yes           N/A
                      Administered to HIV-1-Infected Subjects,
                      as Measured by the Characteristics of Viral
                      Decay
                      Effect of Recombinant Human TNFR:Fc on
AACTG      ACTG 928   IL-6, TNF-a and Markers of Immune      Concluded         BB2679       Terminated     Yes           N/A
                      Activation in HIV-Infected Subjects

                      A Phase II Study of Adefovir Dipivoxil,
                      Pegylated Interferon Alfa -2A, and Ribavirin
AACTG      A5149                                                   Withdrawn   BB 10777     Withdrawn      Yes           N/A
                      Treatment in HBV and HCV Infected
                      Subjects with HIV Disease

                      A Phase II Study of Weekly Doxorubicin
AACTG      ACTG 006   Treatment of AIDS-Associated Kaposi's      Concluded     29,963       Withdrawn      Yes           N/A
                      Sarcoma

                      Chemotherapy and AZT With or Without
AACTG      ACTG 008   Radiotherapy for High Grade Lymphoma in Concluded        30,026       Withdrawn      Yes           N/A
                      AIDS-Risk Group Members

                      Chemotherapy, Radiotherapy, and AZT for
AACTG      ACTG 009                                           Concluded        30,026       Withdrawn      Yes           N/A
                      AIDS-Related Primary CNS Lymphoma




                                                                    31
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                    Status    IND Number       IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                      An Uncontrolled Trial to Evaluate the
                      Pharmacokinetics and Pharmacodynamics
AACTG      ACTG 010                                            Concluded      30,005          Withdrawn      Yes           N/A
                      of AZT and Acyclovir Given Concomitantly
                      to Patients with HIV Infection

                      The Pharmacokinetics and Bioavailability
AACTG      ACTG 011                                               Concluded   29,982          Withdrawn      Yes           N/A
                      of ddC in Patients with HIV Infection

                      A Multicenter Dose Ranging Clinical Trial
AACTG      ACTG 012   of ddC in the Treatment of Patients with    Concluded   29,982          Withdrawn      Yes           N/A
                      AIDS and Advanced ARC

                      A Phase I Study of AZT and Human
                      Interferon (Recombinant Alpha-2A and
AACTG      ACTG 013                                             Concluded     30,001          Withdrawn      Yes           N/A
                      Lymphoblastoid) in the Treatment of AIDS-
                      Associated Kaposi's Sarcoma

                      A Phase I Study of AZT and Human
                      Interferon (Recombinant Alpha-2A and
AACTG      ACTG 014                                             Concluded     30,001          Withdrawn      Yes           N/A
                      Lymphoblastoid) in the Treatment of AIDS-
                      Associated Kaposi's Sarcoma

                      Foscarnet Treatment of Serious CMV
AACTG      ACTG 015                                               Concluded   30,367          Withdrawn      Yes           N/A
                      Retinitis Infection in Patients with AIDS




                                                                    32
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      An Evaluation of Escalating Doses of
                      Intravenous Trimetrexate as Therapy for
AACTG      ACTG 018   Previously Untreated PCP in AIDS          Concluded   30,006          Withdrawn      Yes           N/A
                      Patients, with Subsequent Comparison of
                      Intravenous and Oral Pharmacokinetics

                      A Controlled Comparative Trial of
                      TMP/SMX versus Aerosolized Pentamidine
AACTG      ACTG 021                                            Concluded    31,372          Withdrawn      Yes           N/A
                      for Secondary Prophylaxis of PCP in AIDS
                      Patients Receiving AZT

                      An Open Label, Multiple Dose Ranging
AACTG      ACTG 022   Trial of AL721 in Patients with PGL and   Concluded   30,241          Withdrawn      Yes           N/A
                      Symptomatic HIV Infection

                      A Multicenter Study to Determine
                      Foscarnet Dose Response in HIV Infected
AACTG      ACTG 028                                           Concluded     30,367          Withdrawn      Yes           N/A
                      Patients with PGL and/or Constitutional
                      Disease

                      A Randomized, Comparative, Double-Blind
                      Trial of Trimetrexate with Leucovorin
                      Calcium Rescue versus TMP/SMX for
AACTG      ACTG 029                                            Concluded    30,006          Withdrawn      Yes           N/A
                      Moderately Severe PCP in Patients with
                      AIDS, Followed by Open-Label Aerosolized
                      Pentamidine Prophylaxis




                                                                  33
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                      Status   IND Number     IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      A Randomized, Comparative, Trial of
                      Trimetrexate with Leucovorin Rescue vs
                      Standard Anti-PCP Therapy with High
AACTG      ACTG 030                                            Concluded        30,006       Withdrawn      Yes           N/A
                      Dose Steroids for AIDS Patients with PCP
                      who Appear to Be Refractory to
                      Conventional TX
                      A Randomized, Comparative, Double-Blind
                      Trial of Trimetrexate with Leucovorin
AACTG      ACTG 031   Calcium Rescue versus TMP/SMX for       Concluded         30,006       Withdrawn      Yes           N/A
                      Moderately Severe PCP in Patients with
                      AIDS
                      A Multicenter Phase I Clinical Trial of
                      Ribavirin in the Treatment of Patients with
AACTG      ACTG 034                                                 Concluded   30,845       Withdrawn      Yes           N/A
                      AIDS and Advanced AIDS-Related
                      Illnesses
                      Phase I Pharmacokinetic and Tolerance
AACTG      ACTG 035                                                 Concluded   30,845       Withdrawn      Yes           N/A
                      Study of Ribavirin in HIV-Infected Patients

                      A Phase I Clinical Trial to Evaluate the
                      Toxicity, Antiviral and Immunomodulatory
AACTG      ACTG 038                                              Concluded      39,243       Withdrawn      Yes           N/A
                      Effects of a Range of Doses of Ampligen in
                      HIV-Infected Subjects
                      A Controlled Trial Comparing the Efficacy
                      of Aerosolized Pentamidine and
AACTG      ACTG 040                                             Concluded       31,372       Withdrawn      Yes           N/A
                      Parenteral/Oral TMP/SMX in the Treatment
                      of PCP in AIDS




                                                                      34
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                     Status    IND Number     IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      Aerosols in the Treatment of PCP: A Pilot
                      Study Quantitating the Deposition of
AACTG      ACTG 041   Aerosolized Pentamidine as Delivered in   Concluded      31,372       Withdrawn      Yes           N/A
                      ACTG 040 and Comparing its Toxicity with
                      Parenteral Pentamidine Therapy

                      Interleukin-2 Augmentation of Specific Anti-
                      HIV Immune Responses: Phase I Trial of
                      the Combination of 3'-Azido-3'-
AACTG      ACTG 042   deoxythymidine (ZDV) and Recombinant         Concluded   BB 2928      Withdrawn      Yes           N/A
                      Interleukin-2 in Patients with Asymptomatic
                      HIV Infection Associated with
                      Lymphadenopathy

                      A Phase One Study of AS-101 in Patients
                      with Decreased Absolute CD4 Who are
AACTG      ACTG 046                                            Concluded       31,422       Withdrawn      Yes           N/A
                      Either Asymptomatic or with AIDS-Related
                      Complex (ARC)

                      A Clinical Trial of Alternating and
                      Intermittent Regimens of ddC and AZT in
AACTG      ACTG 047                                              Concluded     31,669       Withdrawn      Yes           N/A
                      the Treatment of Patients with AIDS or
                      Advanced ARC

                      Aerosols in the Treatment of Asymptomatic
                      PCP: A Pilot Study Assessing the
                      Effectiveness of Aerosolized Pentamidine
AACTG      ACTG 048                                             Concluded      31,372       Withdrawn      Yes           N/A
                      as Treatment of Subclinical Pneumocystis
                      Infection in Patients with No Clinical
                      Symptoms



                                                                    35
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                     Status    IND Number     IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      A Trial of Alternating ddC and AZT in the
                      Treatment of Patients with AIDS and ARC
AACTG      ACTG 050                                             Concluded       31,669       Withdrawn      Yes           N/A
                      Who Previously Experienced Hematologic
                      Toxicity from AZT


                      Intermittent Foscarnet Therapy for HIV
AACTG      ACTG 053   Infection in Patients Receiving Long-Term   Concluded     32,144       Withdrawn      Yes           N/A
                      AZT Therapy


                      A Clinical Trial to Evaluate the Toxicity and
                      Antiviral Effects of a Range of Doses of
AACTG      ACTG 054                                                 Concluded   39,243       Withdrawn      Yes           N/A
                      Ampligen in p24 Antigen Positive HIV-
                      Infected Patients with AIDS or ARC

                      A Phase I/II Dose Ranging Trial of Oral
AACTG      ACTG 060   Dextran Sulfate in HIV Infected Individuals Concluded     31,740       Withdrawn      Yes           N/A
                      and in Patients with AIDS or ARC
                      A Multicenter, Double Blind, Comparative
                      Study of AZT Alone versus AZT and
AACTG      ACTG 063   Acyclovir as Treatment for HIV-Infected     Concluded     30,005       Withdrawn      Yes           N/A
                      Patients with CD 4+ Counts Less Than
                      200/mm3

                      An Escalating Dose Tolerance Trial of rsT4
AACTG      ACTG 066                                              Concluded      BB 3034      Withdrawn      Yes           N/A
                      in Patients With AIDS or Advanced ARC




                                                                     36
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                    Status    IND Number      IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      A Safety, Tolerance and Immunological
                      Study of a Combination of Recombinant
AACTG      ACTG 067   Interleukin-2 and Zidovudine in Patients   Concluded     BB 2928       Withdrawn      Yes           N/A
                      with AIDS or AIDS-Related Complex
                      Phase IA/IB

                      A Phase I/II, Open Label Study to Evaluate
                      the Anti-Viral Potential of Combination Low-
AACTG      ACTG 068   Dose Therapy with Zidovudine and             Concluded   30,001        Withdrawn      Yes           N/A
                      Interferon Alpha-2A in Patients with
                      Symptomatic HIV Disease


                      Suppression of CMV Retinitis Utilizing High
AACTG      ACTG 070   Dose Intravenous Acyclovir and Oral AZT Concluded        30,005        Withdrawn      Yes           N/A
                      in Patients with AIDS


                      A Phase I Study to Determine the Safety of
                      the Optimal Monocyte Activating
AACTG      ACTG 072   Administration Schedule of Subcutaneous Concluded        BB 3048       Withdrawn      Yes           N/A
                      Human Recombinant IFN-Gamma in ZDV-
                      Treated Patients with AIDS

                      Phase I Study of Combination
                      Chemotherapy (Adriamycin, Bleomycin,
AACTG      ACTG 075                                             Concluded      30,026        Withdrawn      Yes           N/A
                      and Vincristine) and AZT in the Treatment
                      of AIDS Related Kaposi's Sarcoma




                                                                    37
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
              Study                                                                                          posted on     IND Status
 Network                                Full Title                     Status    IND Number     IND Status   the list on
             Number                                                                                                        Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                     A Pilot Study of Oral Clindamycin and
                     Pyrimethamine for the Treatment of
AACTG      ACTG 077P                                               Concluded     31,441       Withdrawn      Yes           N/A
                     Toxoplasmic Encephalitis in Patients with
                     AIDS

                        Single Dose Pharmacokinetics of Oral
AACTG      ACTG 078     Dextran Sulfate and Intravenous Dextran    Concluded     31,740       Withdrawn      Yes           N/A
                        Sulfate in Healthy Volunteers

                        Aerosols in the Treatment of PCP: A
                        Nested Study Quantitating the Delivery of
AACTG      ACTG 079                                                Concluded     31,372       Withdrawn      Yes           N/A
                        Aerosolized Pentamidine for Prophylaxis of
                        PCP in Protocol ACTG 021 and ACTG 081
                        A Randomized Trial of Three Anti-
                        Pneumocystis Agents Plus Zidovudine for
AACTG      ACTG 081     the Primary Prevention of Serious          Concluded     32,622       Withdrawn      Yes           N/A
                        Infections in Patients with Advanced HIV
                        Infection

                        A Phase I/II Open-Labelled Trial of
                        Intravitreal Ganciclovir Salvage Therapy for
AACTG      ACTG 085                                                  Concluded   32,350       Withdrawn      Yes           N/A
                        AIDS Patients with Active CMV Retinitis
                        Who Are Intolerant of Systemic Therapy




                                                                      38
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                  Status     IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Phase II Randomized Controlled Trial of
                      Immediate versus Delayed Foscarnet
                      Therapy in AIDS Patients with Non-
AACTG      ACTG 092                                             Withdrawn   30,367          Withdrawn      Yes           N/A
                      Immediately Sight-Threatening CMV
                      Retinitis Who Cannot be Treated with
                      Ganciclovir Due to Myelosuppression
                      A Phase II Randomized, Dose-Ranging,
                      Open-Labelled Trial of Foscarnet Salvage
                      Therapy for AIDS Patients with Sight-
AACTG      ACTG 093                                            Concluded    30,367          Withdrawn      Yes           N/A
                      Threatening CMV Retinitis Who Cannot be
                      Treated with Ganciclovir Due to
                      Myelosuppression or Treatment Failure

                      Treatment of Acyclovir-resistant
                      Mucocutaneous Herpes Simplex Infection
                      in Patients with AIDS: A Randomized
AACTG      ACTG 095                                            Concluded    30,367          Withdrawn      Yes           N/A
                      Multicenter Study of Foscarnet vs
                      Vidarabine ** (Includes Non-Randomized
                      Patients -See Accrual by Site Matrix) **

                      A Phase II Study of Zidovudine and
                      Recombinant Alpha-2A Interferon in the
AACTG      ACTG 096                                            Concluded    30,001          Withdrawn      Yes           N/A
                      Treatment of Patients with AIDS-
                      Associated Kaposi's Sarcoma

                      Pyrimethamine Pharmacokinetics in HIV-
AACTG      ACTG 102   Positive Patients Seropositive for       Concluded    35,329          Withdrawn      Yes           N/A
                      Toxoplasma gondii




                                                                  39
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      Continuous High Dose Intravenous
                      Dextran Sulfate in Human
AACTG      ACTG 105                                             Concluded   31,740          Withdrawn      Yes           N/A
                      Immunodeficiency Virus-Infected
                      Individuals
                      A Phase III Comparative Trial of
                      Dapsone/Trimethoprim and
                      Clindamycin/Primaquine Versus
AACTG      ACTG 108                                             Concluded   36,221          Withdrawn      Yes           N/A
                      Trimethoprim/Sulfamethoxazole in the
                      Treatment of Mild-to-Moderate PCP in
                      Patients with AIDS

                      Randomized Trial of BV (Bleomycin +
AACTG      ACTG 109   Vincristine) + AZT Versus BV in Advanced Withdrawn    30,026          Withdrawn      Yes           N/A
                      AIDS-related Kaposi's Sarcoma


                      A Randomized Unblinded Trial Of
                      Zidovudine Versus ddC in the Treatment of
AACTG      ACTG 112   Patients Status Post PCP Who Received Concluded       31,669          Withdrawn      Yes           N/A
                      Long-Term Zidovudine Therapy in Protocol
                      ACTG 002


                      A Phase II/III Trial of Rifampin,
                      Ciprofloxacin, Clofazimine, Ethambutol,
AACTG      ACTG 135   and Amikacin in the Treatment of          Concluded   36,107          Withdrawn      Yes           N/A
                      Disseminated Mycobacterium Avium
                      Infection in HIV-Infected Individuals




                                                                  40
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      The Effect of Gastric pH on the
AACTG      ACTG 136   Bioavailability of Phosphonoformate (PFA, Concluded     30,367         Withdrawn      Yes           N/A
                      Foscarnet)

                      A Pilot Study Evaluating Penicillin G and
                      Ceftriaxone as Therapies for Presumed
AACTG      ACTG 145                                               Concluded   36,426         Withdrawn      Yes           N/A
                      Neurosyphilis in HIV Seropositive
                      Individuals

                      A Phase I Dose Escalation Study of
                      Synthetic Hypericin in HIV Infected
AACTG      ACTG 150                                               Concluded   35,696         Withdrawn      Yes           N/A
                      Patients with Less Than 300 CD4
                      Lymphocytes
                      Phase I Open-Labeled Study of Long-Term
                      Combined or Alternating
                      Foscarnet/Ganciclovir Maintenance
AACTG      ACTG 151                                           Concluded       36,035         Withdrawn      Yes           N/A
                      Therapy for AIDS Patients with CMV
                      Retinitis after Ganciclovir Induction
                      Therapy
                      Primary Prophylaxis of Cerebral
AACTG      ACTG 154                                               Concluded   35,329         Withdrawn      Yes           N/A
                      Toxoplasmosis in HIV-Infected Patients

                      A Randomized, Double Blind Comparative
                      Study of Dideoxycytidine (ddC) Alone or
AACTG      ACTG 155   ddC/ZDV Combination Versus Zidovudine Concluded         31,669         Withdrawn      Yes           N/A
                      (ZDV) Alone in Patients with HIV Infection
                      Who Have Received Prior ZDV Therapy




                                                                    41
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                     Status   IND Number       IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                      Pentoxifylline (Trental) as a Modulator of
AACTG      ACTG 160   Tumor Necrosis Factor and of HIV             Concluded   36,880         Withdrawn      Yes           N/A
                      Replication in Patients with AIDS



                      Phase I/II Study of Combination
                      Chemotherapy (Adriamycin, Bleomycin, +/-
AACTG      ACTG 163   Vincristine) and Dideoxyinosine (ddI) or  Concluded      37,666         Withdrawn      Yes           N/A
                      Dideoxycytidine (ddC) in the Treatment of
                      AIDS-Related Kaposi's Sarcoma



                      An Assessment of In Vivo Biological
AACTG      ACTG 166   Effects of Diethyldithiocarbamate (DTC) in Concluded     37,087         Withdrawn      Yes           N/A
                      HIV-Infected Patients

                      Treatment of Acyclovir Resistant
                      Mucocutaneous Herpes Simplex Virus
AACTG      ACTG 172                                               Concluded    37,269         Withdrawn      Yes           N/A
                      Infection in Patients with AIDS: Open Label
                      Pilot Study of Topical Trifluridine

                      Escalating Multiple-Dose Safety and
AACTG      ACTG 173   Tolerance of WR 6026 Hydrochloride in        Concluded   38,429         Withdrawn      Yes           N/A
                      HIV-Infected Patients




                                                                     42
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Randomized, Double-blind Phase II/III
                      Trial of Monotherapy vs. Combination
AACTG      ACTG 175   Therapy with Nucleoside Analogues in HIV- Concluded    38,265         Withdrawn      Yes           N/A
                      infected Persons with CD4 Cells >/= 200
                      and </= 500/cmm

                      Management of HIV Infected Patients at
                      Risk of Recurrent Purulent Sinusitis: Role
AACTG      ACTG 186                                              Withdrawn   40,274         Withdrawn      Yes           N/A
                      of Anti-Inflammatory, Antibacterial, and
                      Decongestant Prophylaxis

                      A Phase I Concentration-Targeted
AACTG      ACTG 187   Multidose Study of Atevirdine Mesylate     Concluded   38,267         Withdrawn      Yes           N/A
                      (ATV) (U-87201E)

                      Double Blind Placebo Controlled Trial of
                      Paromomycin for Treatment of
AACTG      ACTG 192   Cryptosporidiosis in Patients with         Concluded   40,711         Withdrawn      Yes           N/A
                      Advanced HIV Disease with CD4 Counts
                      Under 150
                      A Randomized, Double-Blind, Three-Arm
                      Study Comparing Combination to
                      Alternating Nucleoside Therapy for the
AACTG      ACTG 193                                          Concluded       38,265         Withdrawn      Yes           N/A
                      Treatment ofAdvanced HIV Disease (CD4
                      </= 50/mm3) with a History of Prior
                      Nucleoside Therapy




                                                                   43
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status    IND Number      IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Prospective Randomized Comparative
                      Study of the Safety & Efficacy of
                      Clarithromycin vs Rifabutin vs the Comb of
AACTG      ACTG 196   Clari PLUS Rifa for the Prevention of MAC Concluded     41,373        Withdrawn      Yes           N/A
                      Bacteremia or Disseminated MAC Disease
                      in HIV-Infected Pts with CD4 <100
                      cells/mm3
                      A Randomized Phase II Study of Two
                      Doses of Interferon alpha-2a (IFN alpha-
                      2a) in Combination with Zidovudine (ZDV)
AACTG      ACTG 197                                               Concluded   31,669        Withdrawn      Yes           N/A
                      and Dideoxycytidine (ddC) Versus ZDV
                      and ddC Only in Patients with HIV Infection
                      and Less Than 400 CD4 Cells/mm3

                      A Phase I Concentration-Controlled Trial to
                      Assess the Safety, Tolerance,
                      Pharmacokinetic and Development of
AACTG      ACTG 199                                               Concluded   38,267        Withdrawn      Yes           N/A
                      Decreased HIV-1 Susceptibility to the
                      Combination of Atevirdine Mesylate (U-
                      87201E), Zidovudine and ddI.

                      A Phase I, Dose Escalating Safety and
AACTG      ACTG 201   Tolerance Study of sCD4-PE40 in HIV-      Concluded     BB 4442       Withdrawn      Yes           N/A
                      Infected Persons




                                                                   44
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
              Study                                                                                          posted on     IND Status
 Network                                Full Title                    Status   IND Number       IND Status   the list on
             Number                                                                                                        Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                     A Phase I Pilot Study of the Safety and
                     Efficacy of Alpha-Interferon (IFN-a2b) in
                     Combination with Nucleoside Analogue
AACTG      ACTG 203P                                           Concluded       BB 4878        Withdrawn      Yes           N/A
                     Therapy in Patients with Combined Chronic
                     Hepatitis C and Advanced Human
                     Immunodeficiency Virus (HIV) Infections


                       A Phase I Multicenter Clinical Trial to
                       Evaluate the Safety and Immunogenicity of
AACTG      ACTG 205                                              Concluded     BB 3671        Withdrawn      Yes           N/A
                       Immuno-AG Recombinant HIV GP160 in
                       Asymptomatic HIV Seropositive Volunteers


                       A Phase I/II Study of Delayed-Type
AACTG      ACTG 221    Hypersensitivity (DTH) Reactions to         Concluded   BB5177         Withdrawn      Yes           N/A
                       Intradermal, HIV-Envelope Antigen

                       A Treatment of Pulmonary Mycobacterium
AACTG      ACTG 222                                           Concluded        41,372         Withdrawn      Yes           N/A
                       Tuberculosis in HIV Infection
                       A Phase I/II Study of Recombinant
AACTG      ACTG 224    Interleukin-4 in AIDS and Kaposi's          Concluded   BB 4950        Withdrawn      Yes           N/A
                       Sarcoma
                       Phase I Clinical Trial to Study Toxicity,
                       Pharmacokinetics, and Efficacy of the
AACTG      ACTG 232    Human Monoclonal Antibody F105 for          Concluded   BB 5090        Withdrawn      Yes           N/A
                       Treatment of Human Immunodeficiency
                       Virus Infection




                                                                     45
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                                Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                      Phase II Randomized Open-Label Trial of
                      Atovaquone plus Pyrimethamine and
AACTG      ACTG 237   Atovaquone plus Sulfadiazine for the        Concluded   44,387          Withdrawn      Yes           N/A
                      Treatment of Acute Toxoplasmic
                      Encephalitis
                      A Phase II/III Double-Blind Study of
AACTG      ACTG 242   Amitriptyline and Mexilitine for Painful    Concluded   44,014          Withdrawn      Yes           N/A
                      Neuropathy in HIV Infection

                      A Phase I/II Double-Blind Controlled Trial
                      To Determine The Safety and
                      Immunogenicity of HIV-1 MN rgp 160
AACTG      ACTG 246                                              Concluded    BB 6076         Withdrawn      Yes           N/A
                      Immuno VaccineTherapy in HIV Infected
                      Individuals with >/= 500/mm3 CD4+ T Cells
                      and 200-400/mm3 CD4 T Cells


                      A Pharmacologically-Guided Phase I/II
AACTG      ACTG 258   Study of Oral Synthetic Hypericin           Concluded   35,696          Withdrawn      Yes           N/A
                      (VimRxyn) in the Therapy of HIV Infection


                      The Evaluation of the Anti-HIV Activity of
                      Two Doses of SC-49483 in Combination
                      with Zidovudine (ZDV) Versus ZDV in
AACTG      ACTG 259                                              Concluded    44,154          Withdrawn      Yes           N/A
                      Patients with HIV Disease and 150-350
                      CD4 Cells/mm3 and Limited
                      Antiretroviral Therapy




                                                                    46
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                     Status    IND Number     IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      Randomized, Phase I/II Dose Ranging,
AACTG      ACTG 260   Open Label Trial of the Anti-HIV Activity of Concluded    45,914       Withdrawn      Yes           N/A
                      Delavirdine Mesylate (U-90,152S)

                      A Phase II Double-Blind Study of
                      Delavirdine (DLV) in Combination with
AACTG      ACTG 261                                            Concluded        45,914       Withdrawn      Yes           N/A
                      Zidovudine (ZDV) and/or Didanosine (ddI)
                      versus ZDV and ddI Combination Therapy

                      A Phase II, Double-Masked, Randomized,
                      Placebo Controlled Evaluation of Standard
                      Therapy vs. Standard Therapy Combined
AACTG      ACTG 266   with Human Monoclonal Anti-               Concluded       BB 6073      Withdrawn      Yes           N/A
                      Cytomegalovirus Antibody (MSL 109) in the
                      Therapy of AIDS Patients with
                      Cytomegalovirus (CMV) Retinitis

                      A Phase I Placebo-Controlled, Dose-
                      Escalation Study of the Safety, Tolerability,
AACTG      ACTG 267                                                 Concluded   46,240       Withdrawn      Yes           N/A
                      and Pharmacokinetics of Thalidomide in
                      Subjects with HIV-1 Infection

                      Gradual Initiation of TMP/SMX as Primary
AACTG      ACTG 268                                            Concluded        46,533       Withdrawn      Yes           N/A
                      PCP Prophylaxis

                      A Phase II Randomized, Double-Blind,
                      Placebo-Controlled Trial to Determine the
AACTG      ACTG 271                                               Concluded     47,117       Withdrawn      Yes           N/A
                      Efficacy of Prednisone Therapy in HIV-
                      Associated Nephropathy (HIVAN)




                                                                     47
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)

                      CPCRA 034: A Randomized, Comparative
                      Study of Daily Dapsone and Daily
AACTG      ACTG 277   Atovaquone for Prophylaxis Against PCP in Concluded    45,799         Withdrawn      Yes           N/A
                      HIV-Infected Patients Who are Intolerant of
                      Trimethoprim and/or Sulfonamides

                      A Phase II Randomized Study of the
                      Virologic and Immunologic Effects of d4T
                      vs ddI vs Zidovudine + d4T vs Zidovudine
AACTG      ACTG 290   + ddI in HIV-Infected Patients with CD4    Concluded   47,711         Withdrawn      Yes           N/A
                      Cell Counts Between 300-600/mm3 and
                      Greater than 24 Weeks Zidovudine
                      Experience

                      A Phase II, Double-Blind Trial Of
                      Recombinant Human Nerve Growth Factor
AACTG      ACTG 291                                           Concluded      BB 6504        Withdrawn      Yes           N/A
                      for Treatment of HIV-Associated Sensory
                      Neuropathy

                      A Phase II Trial of Amphotericin B Oral
AACTG      ACTG 295   Suspension for Fluconazole-Resistant Oral Concluded    47,890         Withdrawn      Yes           N/A
                      Candidiasis in HIV-Infected Patients
                      A Phase II Randomized Study of the
                      Virologic and Immunologic Effects of
                      Zidovudine Plus Lamivudine (3TC) vs. d4T
AACTG      ACTG 298   vs. Zidovudine plus d4T in HIV-Infected  Concluded     48,608         Withdrawn      Yes           N/A
                      Patients with CD4 Cell Counts Between
                      300-600/mm3 and No Previous Nucleoside
                      Experience


                                                                   48
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      Virologic Responses to New Nucleoside
AACTG      ACTG 302   Regimens After Prolonged ZDV or ddI         Concluded   48,608         Withdrawn      Yes           N/A
                      Monotherapy
                      Influence of Risk Status for Disease
                      Progression on the Response to
AACTG      ACTG 303                                               Concluded   48,607         Withdrawn      Yes           N/A
                      Antiretroviral Interventions: A Follow-Up
                      Study to ACTG 175
                      A Pilot Treatment Study of CSF
                      Penetration and Response to Ganciclovir
AACTG      ACTG 305                                               Withdrawn   36,035         Withdrawn      Yes           N/A
                      and Foscarnet in Presumed CMV
                      Neurologic Disease

                      A Phase II, Randomized Study of the
                      Antiviral Activity and Resistance
                      Interactions of 3TC + ZDV, D4T, or DDI vs.
AACTG      ACTG 306                                              POS PAC      48,608         Withdrawn      Yes           N/A
                      Monotherapy DDI or D4T in HIV-Infected
                      Individuals with 200-600 CD4 Cells and No
                      previous Nucleoside Experience

                      Double-Blind Randomized Comparison
                      Phase II Trial of Megestrol Acetate and
                      Testosterone Enanthate in Combination vs.
AACTG      ACTG 313                                             POS PAC       51,575         Withdrawn      Yes           N/A
                      Megestrol Acetate Plus Testosterone
                      Enanthate Placebo in HIV-Associated
                      Wasting

                      Phase II Study of WR 6026 for
AACTG      ACTG 314   Pneumocystis carinii Pneumonia in People Concluded      38,429         Withdrawn      Yes           N/A
                      with HIV Infection




                                                                    49
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                     Status    IND Number     IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      The Anti-Viral Effect of Switching from
                      Saquinavir to the New Formulation of
AACTG      ACTG 333                                                 Concluded   50,722       Withdrawn      Yes           N/A
                      Saquinavir vs. Switching to Indinavir After >
                      1 year of Saquinavir Use

                      Effect of Vaccination on Turnover of
                      Lamivudine (3TC) Sensitive and Resistant
AACTG      ACTG 340                                            Withdrawn        48,608       Withdrawn      Yes           N/A
                      Virus Populations in HIV-1-Infected
                      Individuals
                      A Randomized, Double-Blind Phase 2
                      Study of VX-478 Monotherapy vs VX-478
AACTG      ACTG 347                                               Concluded     52,187       Withdrawn      Yes           N/A
                      plus ZDV plus 3TC in HIV Infected
                      Individuals

                      ACTG 817, a Substudy of ACTG 222:
                      Pharmacokinetics of Antituberculous
AACTG      ACTG 817   Agents in HIV-Infected Persons with         Withdrawn     41,372       Withdrawn      Yes           N/A
                      Tuberculosis (A Substudy of ACTG
                      222/CPCRA 019)


                      ACTG 825 is an intensive virology
AACTG      ACTG 825   substudy of ACTG 261: DLV + ZDV and/or Concluded          45,914       Withdrawn      Yes           N/A
                      ddI vs. ZDV + ddI

                      ACTG 826 is a pharmacology substudy of
AACTG      ACTG 826   ACTG 261, Delavirdine Mesylate              Concluded     45,914       Withdrawn      Yes           N/A
                      Population Pharmacokinetics




                                                                     50
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)

                      ACTG 827, a Substudy in ACTG 266:
                      Determination of the Influence of MSL 109
AACTG      ACTG 827   Administration on Antibody Dependent      Concluded    BB 6073        Withdrawn      Yes           N/A
                      Cellular Cytotoxicity (ADCC) versus CMV-
                      Infected Cell Targets

                      ACTG 828 is a substudy of 271 -
                      Spontaneous and Lipopolysaccharide
AACTG      ACTG 828   Induced Ex-Vivo Production of Interleukin- Concluded   47,117         Withdrawn      Yes           N/A
                      1, -6, Tumor Necrosis Factor-Alpha and
                      Lymphocyte Proliferation Assay

                      ACTG 834 is an Immunology Substudy for
AACTG      ACTG 834   ACTG 263 entitled Quantitative         Withdrawn       BB 5630        Withdrawn      Yes           N/A
                      Assessments of CD8 CTL Activity

                      ACTG 835 is an Immunology Substudy to
                      ACTG 263 entitled Assessments of CD8
AACTG      ACTG 835                                             Withdrawn    BB 5630        Withdrawn      Yes           N/A
                      Suppressor Activity Against Autologous
                      HIV-Infected PBMC
                      ACTG 837, a Substudy in ACTG 266:
                      Determination of the Pharmacokinetic
AACTG      ACTG 837   Disposition of MSL 109 in a Subgroup of   Concluded    BB 6073        Withdrawn      Yes           N/A
                      Subjects with HIV Disease Under Steady
                      State Conditons




                                                                  51
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                              Full Title                     Status    IND Number      IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      ACTG 857 is a Virology Substudy of ACTG
                      298: Rates of HIV RNA Clearance After
AACTG      ACTG 857   Administration of Zidovudine (ZDV) versus Concluded      48,608        Withdrawn      Yes           N/A
                      Stavudine (D4T) versus ZDV plus D4T in
                      Nucleoside Naive Patients

                      ACTG 859 is a substudy of ACTG 303 -
AACTG      ACTG 859                                               Concluded    48,607        Withdrawn      Yes           N/A
                      Viral Dynamics

                      ACTG 860 is a Substudy of ACTG 291:
AACTG      ACTG 860   Recombinant Nerve Growth Factor Biopsy Concluded         BB 6504       Withdrawn      Yes           N/A
                      Specimen Trial
                      ACTG 862 is a Clinical Pharmacology
                      Substudy of ACTG 306 to evaluate
                      eventual interactions in plasma and cells
AACTG      ACTG 862                                                  POS PAC   48,608        Withdrawn      Yes           N/A
                      between ZDV, or d4T or ddI, and 3TC and
                      their respective intracellular 5'-triphosphate
                      levels.
                      Version 5, ACTG 221, (Part 2), "A Phase
                      I/II Study of Delayed-Type-Hypersensitivity
AACTG      ACTG 921   (DTH) Reactions to Intradermal HIV          Concluded    BB5177        Withdrawn      Yes           N/A
                      Envelope Antigen," in which subjects were
                      re-enrolled & given a new skin test antigen




                                                                     52
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)

                      A Phase I/II Double-Blind Controlled Trial
                      To Determine The Safety and
AACTG      ACTG 946   Immunogenicity of HIV-1 MN rgp 160         Concluded   BB 6076        Withdrawn      Yes           N/A
                      Immuno Vaccine Therapy in HIV Infected
                      Individuals with >/= 50/mm3 CD4+ T Cells

                      Randomized Comparative Study of
                      Fluconazole versus Clotrimazole Troches
                      in the Prevention of Serious Fungal
AACTG      ACTG 981                                             Concluded    32,622         Withdrawn      Yes           N/A
                      Infection in Patients with AIDS or
                      Advanced AIDS-related Complex (A
                      Nested Study of ACTG 081)
                      A Phase II, Randomized, Partially Blinded
                      Trial of Combinations of Potent
                      Antiretroviral Therapy, HIV-Specific
AACTG      A5024                                                 Concluded   BB 9083        Inactive       Yes           N/A
                      Immunizations, and Cycles of Interleukin-2
                      to Promote Efficient Control of Viral
                      Replication
                      A Phase III, Prospective, Randomized,
                      Double-Blind Trial of Valganciclovir Pre
AACTG      A5030      Emptive Therapy for Cytomegalovirus        POS PAC     60,075         Inactive       Yes           N/A
                      (CMV) Viremia as Detected by Plasma
                      CMV DNA PCR Assay
                      Pharmacokinetic Interaction Studies of
                      Amprenavir(APV), Efavirenz (EFV), and a
AACTG      A5043                                                 POS PAC     59,279         Inactive       Yes           N/A
                      Second Protease Inhibitor in Seronegative
                      Volunteers




                                                                  53
                                           ACTG IND studies, CRF Destruction March 2010


                                                                                                         Was
                                                                                                         protocol
             Study                                                                                       posted on     IND Status
 Network                            Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                     Change Date
                                                                                                         the RCC
                                                                                                         Website
                                                                                                         (Yes/No)
                     A Phase I/II, Randomized, Open-Label
                     Study of the Safety and Pharmacokinetics
                     of Indinavir + Ritonavir Therapy in HIV-
AACTG      A5055     Infected Subjects Failing Amprenavir,     Concluded   59,143         Inactive       Yes           N/A
                     Nelfinavir, Saquinavir, or
                     Nelfinavir/Saquinavir Combination
                     Therapy.
                     A Randomized Phase I/II Pilot Study of
                     Intermittent Withdrawal of Antiretroviral
                     Therapy as an Immunization Strategy and
                     Double-Blinded Immunization with ALVAC-
AACTG      A5068                                               POS PAC     BB 9572        Inactive       Yes           N/A
                     HIV vCP1452 in Subjects with Persistent
                     CD4+ Cell Counts Greater than 400
                     cells/mm3 and Plasma HIV-1 RNA Levels
                     < 50 copies/ml
                     A Prospective, Multicenter, Randomized,
                     Placebo-Controlled Trial Of Physiologic
                     Testosterone Supplementation for HIV-
AACTG      A5079                                               Concluded   62,144         Inactive       Yes           N/A
                     Positive Men With Mildly to Moderately
                     Reduced Serum Testosterone Levels and
                     Abdominal Obesity

                     Phase II, Placebo-Controlled, Double-Blind
                     Study of the Selegiline Transdermal
AACTG      A5090                                                POS PAC    61,906         Inactive       Yes           N/A
                     System (STS) in the Treatment of HIV-
                     Associated Cognitive Impairment




                                                                 54
                                            ACTG IND studies, CRF Destruction March 2010


                                                                                                          Was
                                                                                                          protocol
             Study                                                                                        posted on     IND Status
 Network                             Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                      Change Date
                                                                                                          the RCC
                                                                                                          Website
                                                                                                          (Yes/No)
                     Phase III, Randomized, Double-Blind
                     Comparison of Three Protease Inhibitor-
AACTG      A5095                                                POS PAC    61,731          Inactive       Yes           N/A
                     Sparing Regimens for the Initial Treatment
                     of HIV Infection
                     A Phase II Study of the Predictive Value of
                     Pharmacokinetic-Adjusted Phenotypic
                     Susceptibility (C12h/IC50) on Antiretroviral
AACTG      A5126     Response to Ritonavir-Enhanced Protease POS PAC       63,378          Inactive       Yes           N/A
                     Inhibitors in Subjects with Failure of
                     Previous Protease Inhibitor-Based
                     Regimens
                     A Randomized, Phase II, Controlled Trial
                     Comparing the Efficacy of Adefovir
                     Dipivoxil and Tenofovir Disoproxil
AACTG      A5127                                                 POS PAC   64,077          Inactive       Yes           N/A
                     Fumarate for the Treatment of Hepatitis B
                     Virus in Subjects who are Co-infected with
                     HIV
                     A Phase I/II Study to Evaluate the Safety
                     and Immunogenicity of the Subcutaneous
                     Administration of ALVAC-HIV vCP1452
AACTG      A5130     Infected Autologous Dendritic Cells Versus POS PAC    BB 10041        Inactive       Yes           N/A
                     the Subcutaneous Administration of
                     ALVAC-HIV vCP1452 to HIV-Infected
                     Subjects
                     A Phase III, Randomized, Open-Label
                     Comparison of Lopinavir/Ritonavir Plus
AACTG      A5142     Efavirenz Versus Lopinavir/Ritonavir Plus 2 POS PAC   65,247          Inactive       Yes           N/A
                     NRTIs Versus Efavirenz Plus 2 NRTIs as
                     Initial Therapy for HIV-1 Infection



                                                                 55
                                            ACTG IND studies, CRF Destruction March 2010


                                                                                                          Was
                                                                                                          protocol
             Study                                                                                        posted on     IND Status
 Network                             Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                      Change Date
                                                                                                          the RCC
                                                                                                          Website
                                                                                                          (Yes/No)
                     A RANDOMIZED, COMPARATIVE STUDY
                     OF LOPINAVIR/RITONAVIR VERSUS
                     GW433908 AND RITONAVIR VERSUS
                     LOPINAVIR/RITONAVIR AND GW433908
                     (IN COMBINATION WITH TENOFOVIR
AACTG      A5143                                         POS PAC           63,609          Inactive       Yes           N/A
                     DISOPROXIL FUMARATE AND ONE OR
                     TWO NUCLEOSIDE REVERSE
                     TRANSCRIPTASE INHIBITORS) IN HIV-1-
                     INFECTED SUBJECTS WITH
                     VIROLOGIC TREATMENT FAILURE

                     A Substudy of A5143: Intensive
AACTG      A5147s    Pharmacokinetic (PK) Substudy of         POS PAC      63,609          Inactive       Yes           N/A
                     Lopinavir/Ritonavir/908

                     A Phase I/II Randomized, Double-blind,
                     Placebo-Controlled Pilot Study of ß-D-2,6-
AACTG      A5165     Diaminopurine Dioxolane (DAPD) Versus Concluded       64,609          Inactive       Yes           N/A
                     DAPD Plus Mycophenolate Mofetil (MMF)
                     in Treatment-Experienced Subjects

                     Improving Immune Reconstitution with
                     Growth Hormone in HIV-Infected Subjects
AACTG      A5174     with Incomplete CD4+ Lymphocyte             POS PAC   BB 10828        Inactive       Yes           N/A
                     Restoration on Highly Active Antiretroviral
                     Therapy (HAART)




                                                                 56
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                    Status    IND Number      IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                     An Open-Label, Randomized Study to
                     Determine the Impact of Antiretroviral
                     Treatment in HCV/HIV-Coinfected
AACTG      A5184                                                Concluded     BB 12148      Inactive       Yes           N/A
                     Subjects with High CD4+ Cell Count on the
                     Efficacy of Hepatitis C Treatment with
                     Pegylated Interferon Alfa-2A and Ribavirin

                     A Phase II Trial of the Effect of
                     Combination Therapy with Fish Oil
                     Supplement and Fenofibrate on
AACTG      A5186     Triglyceride (TG) Levels in Subjects on     POS PAC      68,568        Inactive       Yes           N/A
                     Highly Active Antiretroviral Therapy
                     (HAART) Who Are Not Responding to
                     Either Fish Oil or Fenofibrate Alone

                     The Effect of Growth Hormone on Thymus
AACTG      A5198S    Size in HIV-Infected Subjects on HAART POS PAC           BB 10828      Inactive       Yes           N/A
                     (A Substudy of A5174)

                     A Randomized, Placebo-Controlled, Phase
                     I/II Trial of the Anti-HIV Activity and Safety
AACTG      A5200                                                    POS PAC   71,139        Inactive       Yes           N/A
                     of VGX-410 (Mifepristone) at Three Dose
                     Levels in HIV-1-Infected Subjects

                     A Prospective, Open-Label, Pilot Trial of
                     Regimen Simplification to
AACTG      A5201     Atazanavir/Ritonavir Alone as Maintenance POS PAC        69,775        Inactive       Yes           N/A
                     Antiretroviral Therapy after Sustained
                     Virologic Suppression




                                                                    57
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                      Status   IND Number      IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                      A Pilot Study Evaluating the Effect of the
                      Levonorgestrel-Releasing Intrauterine
AACTG      A5205                                                    POS PAC     70,738        Inactive       Yes           N/A
                      Device on Genital HIV Shedding in HIV-1-
                      infected Women

                      A Phase I, Randomized, Placebo-
                      Controlled, Double-Blind Study Evaluating
                      the Safety of Subcutaneous Single Dose
AACTG      A5214                                                    POS PAC     BB 12069      Inactive       Yes           N/A
                      Interleukin-7 in HIV-1-Infected Subjects
                      Who Are Receiving Antiretroviral
                      Treatment
                      Pilot Study to Determine the Feasibility of
                      Fluconazole for Induction Treatment and
                      Suppression of Relapse of Disseminated
AACTG      ACTG 174                                                 Concluded   37,701        Inactive       Yes           N/A
                      Histoplasmosis in Patients with the
                      Acquired Immunodeficiency Syndrome
                      (AIDS)

                      A Randomized, Double-Blind, Phase III
                      Study of Indinavir Sulfate (IDV) with Open-
                      Label ZDV or Stavudine (d4T) and
AACTG      ACTG 320   Lamivudine (3TC) in Subjects with HIV       POS PAC       49,458        Inactive       Yes           N/A
                      Infection with CD4 Cell Counts <= 200
                      Cells/mm3 and >= 3 Months of Prior
                      Zidovudine (ZDV) Experience




                                                                      58
                                             ACTG IND studies, CRF Destruction March 2010


                                                                                                           Was
                                                                                                           protocol
             Study                                                                                         posted on     IND Status
 Network                              Full Title                   Status    IND Number       IND Status   the list on
            Number                                                                                                       Change Date
                                                                                                           the RCC
                                                                                                           Website
                                                                                                           (Yes/No)
                      A Phase IV Randomized Study of the Use
                      of Fluconazole as Chronic Suppressive
AACTG      ACTG 323   Therapy Versus Episodic Therapy in HIV   Concluded    37,701          Inactive       Yes           N/A
                      Positive Subjects with Recurrent
                      Oropharyngeal Candidiasis

                      A Prospective Randomized Double Blind
                      Trial of Three Maintenance Regimens for
AACTG      ACTG 343   HIV Infected Patients Receiving Induction Concluded   49,458          Inactive       Yes           N/A
                      Therapy with Zidovudine, Lamivudine, and
                      Indinavir
                      Comparison of the Virologic Efficacy of
                      Nelfinavir and/or DMP-266 (Efavirenz,
                      EFV) in Combination with One or Two New
AACTG      ACTG 364                                             POS PAC     53,360          Inactive       Yes           N/A
                      Nucleoside Analogs in Nucleoside
                      Experienced Subjects: A Rollover Study of
                      ACTG 302/303

                      A Randomized, Phase II, Placebo
                      Controlled Trial of ABC (Abacavir,
                      1592U89) in Combination with Open Label
AACTG      ACTG 368   IDV (Indinavir Sulfate) and EFV (Efavirenz, POS PAC   49,458          Inactive       Yes           N/A
                      DMP-266) in HIV-Infected Subjects with
                      Nucleoside Analog Experience: A Rollover
                      Study for ACTG 320




                                                                  59
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                      Status   IND Number     IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      ACTG 877 is a Substudy of ACTG 343:
                      Assessment of Viral Burden in Lymph
                      Node Aspirates, Genital Secretions and
AACTG      ACTG 877                                               Concluded     49,458       Inactive       Yes           N/A
                      Cerebral Spinal Fluid in Subjects Receiving
                      Zidovudine (ZDV), Lamivudine (3TC) and
                      Indinavir (IDV)
                      ACTG 878 is a Substudy of ACTG 343:
                      Correlation Between Pharmacology
                      Parameters and Virology Responses, Both
AACTG      ACTG 878                                           Concluded         49,458       Inactive       Yes           N/A
                      in Plasma and CSF of Subjects Receiving
                      Zidovudine (ZDV), Lamivudine (3TC) and
                      Indinavir (IDV)

                      ACTG 879 is a Substudy of ACTG 343:
                      Determination if Cellular Immunity Prior to
                      Therapy Influences the Response to
AACTG      ACTG 879                                                 Concluded   49,458       Inactive       Yes           N/A
                      Therapy and Assessment of the Capacity
                      ofthe Host to Recover Immunity with
                      Suppression or Eradication of HIV-1


                      GM-CSF and ZDV: A Phase I Study of
AACTG      ACTG 065   Concurrent Administration in Patients with    Concluded   BB 3024      Terminated     Yes           N/A
                      AIDS and Severe ARC




                                                                      60
                                            ACTG IND studies, CRF Destruction March 2010


                                                                                                          Was
                                                                                                          protocol
             Study                                                                                        posted on     IND Status
 Network                             Full Title                    Status   IND Number       IND Status   the list on
            Number                                                                                                      Change Date
                                                                                                          the RCC
                                                                                                          Website
                                                                                                          (Yes/No)
                      A Controlled, Randomized Phase II Study
                      of the Safety and Efficacy of Combined
                      Therapy with DHPG and GM-CSF Versus
AACTG      ACTG 073                                             Concluded   BB 3024        Terminated     Yes           N/A
                      Ganciclovir Alone for the Treatment of
                      Sight-Threatening CMV Retinitis in AIDS
                      Patients
                      Phase I Trial of mBACOD and Granulocyte-
                      Macrophage Colony Stimulating Factor in
AACTG      ACTG 074   AIDS-Associated Large Cell,              Concluded    BB 3024        Terminated     Yes           N/A
                      Immunoblastic, and Small Non-Cleaved
                      Lymphoma
                      A Phase I Study of the Combination of
                      Recombinant GM-CSF, AZT, and
AACTG      ACTG 094   Chemotherapy (ABV) (Adriamycin,          Concluded    BB 3024        Terminated     Yes           N/A
                      Bleomycin, Vincristine) in AIDS and
                      Kaposi's Sarcoma
                      A Phase III Randomized Trial of Low-Dose
                      vs. Standard-Dose mBACOD
AACTG      ACTG 142   Chemotherapy with rGM-CSF for            Concluded    BB 3024        Terminated     Yes           N/A
                      Treatment of AIDS-Associated Non-
                      Hodgkin's Lymphoma
                      A Phase II Exploratory Study Examining
                      Immunologic and Virologic Indices in Two
                      Age-Differentiated Cohorts of HIV-Infected
AACTG      A5015                                                 POS PAC    60,387         Inactive       No            10/06/08
                      Subjects to Explore the Basis of
                      Accelerated HIV-Disease Progression
                      Associated with Aging




                                                                  61
                                              ACTG IND studies, CRF Destruction March 2010


                                                                                                            Was
                                                                                                            protocol
             Study                                                                                          posted on     IND Status
 Network                               Full Title                     Status   IND Number      IND Status   the list on
            Number                                                                                                        Change Date
                                                                                                            the RCC
                                                                                                            Website
                                                                                                            (Yes/No)
                      A RANDOMIZED, PHASE II, OPEN-
                      LABEL STUDY TO COMPARE TWICE
                      DAILY AND ONCE DAILY POTENT
                      ANTIRETROVIRAL THERAPY AND TO
AACTG      A5073                                                   POS PAC     60,387        Inactive       No            10/06/08
                      COMPARE SELF-ADMINISTERED
                      THERAPY AND THERAPY
                      ADMINISTERED UNDER DIRECT
                      OBSERVATION
                      A Phase II/III Placebo-Controlled Study of
AACTG      ACTG 336   Nitazoxanide for Persons with AIDS and       Concluded   51,783        Inactive       No            04/24/09
                      Cryptosporidiosis
                      A Phase I/II Open Label Study of
                      Nitazoxanide (NTZ) for the Treatment of
AACTG      ACTG 369                                                Concluded   51,783        Inactive       No            04/24/09
                      Cryptosporidium Parvum in HIV-Infected
                      Infants, Children, and Adolescents
                      An Open-Label, Dose-Escalation Pilot
                      Study Of Acetyl-L-Carnitine For The
AACTG      A5157      Treatment Of Dideoxynucleoside-              Concluded   IND#51        Inactive       No            09/17/09
                      Associated Distal Symmetric Peripheral
                      Neuropathy

                      A Phase III, Randomized, Double-Blind,
                      Placebo-Controlled Evaluation of the Effect
                      of Immunization with a HIV Immunogen on
AACTG      A5057                                                   Concluded   BB8723        Inactive       No            12/08/09
                      the Time to Virologic Relapse in Individuals
                      Receiving Potent, Suppressive
                      Antiretroviral Therapies




                                                                     62
                                               ACTG IND studies, CRF Destruction March 2010


                                                                                                             Was
                                                                                                             protocol
             Study                                                                                           posted on     IND Status
 Network                               Full Title                     Status   IND Number       IND Status   the list on
            Number                                                                                                         Change Date
                                                                                                             the RCC
                                                                                                             Website
                                                                                                             (Yes/No)
                      Augmentation of HIV-Specific Helper and
                      CTL Responses Through Therapeutic
AACTG      A5058s                                                 POS PAC      BB8723         Inactive       No            12/08/09
                      Vaccination in Individuals Receiving Potent
                      Suppressive Antiretroviral Therapies

                      A Rollover Study of A5058s: A Phase II
                      Trial to Evaluate the Ability of Vaccine-
AACTG      A5172      Induced Helper and CTL Responses to          POS PAC     BB8723         Inactive       No            12/08/09
                      Control Viremia in the Absence of
                      Antiretroviral Therapy

                      Phase I/II Trial of Subcutaneous IL-2 with
                                                                  Closed to
AACTG      ACTG 402   Highly Active Antiretroviral Therapy in HIV              BB8826         Inactive       No            04/02/09
                                                                  Follow Up
                      Infected Children with Immunosuppression.


                      A Pilot Study of Low Dose Interleukin-2 (IL-
                      2) with the Addition of Pegylated Interferon
AACTG      A5088      (PEG-IFN alfa-2b) and Ribavirin (RBV) for Concluded      BB9722         Inactive       No            01/12/10
                      the Treatment of Hepatitis C Infection in
                      Subjects with HIV Co-Infection

                      Safety, Tolerability, and Pharmacokinetic
AACTG      A5213      Interactions of Atazanavir and Rifampin in   Concluded   70,910         Inactive       No            03/01/10
                      Healthy Volunteers




                                                                     63
                                              PACTG IND studies, CRF Destruction March 2010



                                                                                                         Was protocol
                                                                                                         posted on the IND Status
             Study                                                                     IND
Network                                 Full Title                        Status              IND Status list on the   Change
            Number                                                                   Number
                                                                                                         RCC Website Date
                                                                                                         (Yes/No)

                     A Phase I Evaluation of AZT in Children with
PACTG     ACTG 003                                                  POS PAC         28,972    Inactive    Yes          N/A
                     AIDS or ARC
                     A Double-Blind, Placebo-Controlled Trial to
PACTG     ACTG 051   Evaluate IVIG in Children with Symptomatic HIV POS PAC         BB3022    Inactive    Yes          N/A
                     Infection Receiving AZT

                     A Multicenter Placebo-Controlled Trial to
                     Evaluate the Safety and Efficacy of Oral AZT in
PACTG     ACTG 052                                                    POS PAC       28,972    Inactive    Yes          N/A
                     the Treatment of Children Infected with HIV with
                     Mild to Moderate Symptoms (Including LIP)

                     A Phase III Randomized, Placebo-Controlled
                     Trial to Evaluate the Efficacy, Safety and
PACTG     ACTG 076                                                   POS PAC        28,972    Inactive    Yes          N/A
                     Tolerance of Zidovudine for the Prevention of
                     Maternal-Fetal HIV Transmission

                     A Phase I Trial to Evaluate AZT in HIV-1
                     Infected Pregnant Women and Their Offspring
PACTG     ACTG 082                                                  POS PAC         28,972    Inactive    Yes          N/A
                     and a Phase I Pharmacokinetic and Safety Trial
                     of AZT in Laboring Women and Their Offspring
                     A Phase I Study of the Safety, Tolerance and
                     Pharmacokinetics of Aerosolized Pentamidine
PACTG     ACTG 115   and Parenteral Pentamidine in Children with HIV POS PAC        31,372    Withdrawn   Yes          N/A
                     Infection and Suspected Pneumocystis Carinii
                     Pneumonia
                     A Randomized Blinded Trial to Evaluate the
                     Safety and Tolerance of High Versus Low Dose
PACTG     ACTG 128                                                   POS PAC        28,972    Inactive    Yes          N/A
                     Zidovudine Administered to Children with Human
                     Immunodeficiency Virus



                                                                     64
                                              PACTG IND studies, CRF Destruction March 2010



                                                                                                         Was protocol
                                                                                                         posted on the IND Status
             Study                                                                     IND
Network                                 Full Title                        Status              IND Status list on the   Change
            Number                                                                   Number
                                                                                                         RCC Website Date
                                                                                                         (Yes/No)

                     Phase II Study to Evaluate the Safety, Tolerance
                     and Efficacy of Hyperimmune Anti-HIV
PACTG     ACTG 131                                                    Withdrawn     BB3843    Withdrawn   Yes          N/A
                     Intravenous Immuno-globulin and of Zidovudine
                     in Infants with Documented HIV Infection
                     A Trial of Two Doses of 2',3'-Dideoxycytidine
                     (ddC) in the Treatment of Children with
PACTG     ACTG 138   Symptomatic HIV Infection Who are Intolerant of POS PAC        35,692    Withdrawn   Yes          N/A
                     Zidovudine and/or Show Progressive Disease
                     while on Zidovudine
                     Randomized Comparative Trial of Two Doses of
                     2'3'-Dideoxyinosine (ddI) in Children with
PACTG     ACTG 144   Symptomatic HIV Infection Who are Either        POS PAC        31,945    Inactive    Yes          N/A
                     Unresponsive to Zidovudine and/or Who are
                     Intolerant to Zidovudine
                     Randomized Comparative Trial of Zidovudine
                     (ZDV) Versus 2'3'Dideoxyinosine (ddI) Versus
PACTG     ACTG 152                                                   POS PAC        35,208    Inactive    Yes          N/A
                     ZDV Plus ddI in Symptomatic HIV-Infected
                     Children

                     Safety, and Tolerance of Zidovudine and
PACTG     ACTG 153                                                   POS PAC        30,001    Withdrawn   Yes          N/A
                     Interferon-Alpha-2A in HIV-Infected Children


                     A Controlled Randomized Trial to Study the
                     Efficacy of Adjunctive Methylprednisolone for the
PACTG     ACTG 170                                                     Withdrawn    38,362    Withdrawn   Yes          N/A
                     Treatment of Pneumocystis Carinii Pneumonia
                     in Pediatric AIDS Patients




                                                                     65
                                              PACTG IND studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the IND Status
             Study                                                                      IND
Network                                  Full Title                          Status             IND Status list on the   Change
            Number                                                                    Number
                                                                                                           RCC Website Date
                                                                                                           (Yes/No)

                     Comparison of Two Dosage Regimens of Oral
PACTG     ACTG 179   Dapsone for Prophylaxis of Pneumocystis carinii POS PAC          38,841    Withdrawn   Yes          N/A
                     Pneumonia in Pediatric HIV Infection
                     Phase III Study to Evaluate the Safety,
                     Tolerance and Efficacy of Early Treatment with
PACTG     ACTG 182                                                      POS PAC       28,972    Inactive    Yes          N/A
                     Zidovudine (ZDV) in Asymptomatic Infants with
                     HIV Infection
                     A Phase I/II Trial of Parenteral Pentamidine for
                     PCP Prophylaxis in HIV-Infected Children Who
PACTG     ACTG 189                                                      POS PAC       31,372    Withdrawn   Yes          N/A
                     Are Intolerant to Oral
                     Trimethoprim/Sulfamethoxazole
                     A Phase II Study to Evaluate Pharmacokinetics,
                     Safety, Tolerance and Activity of Dideoxycytidine
PACTG     ACTG 190   (ddC) Administered in Combination with            POS PAC        35,692    Withdrawn   Yes          N/A
                     Zidovudine (ZDV) in Stable, ZDV-Treated,
                     Pediatric Patients with HIV Infection



                     Phase I/II Study of Recombinant Human
PACTG     ACTG 211   Interferon-Gamma (rIFN-gamma) in HIV-              POS PAC       BB 4827   Withdrawn   Yes          N/A
                     Infected Children


                     A Placebo Controlled, Phase I Clinical Trial to
                     Evaluate the Safety and Immunogenicity of
PACTG     ACTG 218   Recombinant Envelope Proteins of HIV-1 gp160 POS PAC             BB4879    Terminated Yes           N/A
                     and gp120 in Children >= 1 Month Old with
                     Asymptomatic HIV Infection



                                                                        66
                                             PACTG IND studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the IND Status
             Study                                                                        IND
Network                                 Full Title                          Status               IND Status list on the   Change
            Number                                                                      Number
                                                                                                            RCC Website Date
                                                                                                            (Yes/No)

                     A Phase II Comparative Study of
                     Seroconversion of Single-Dose and Two-Dose
                                                                       Closed to Follow
PACTG     ACTG 225   Measles Vaccination in HIV-Infected and HIV-                       BB5799   Withdrawn   Yes          N/A
                                                                       Up
                     Uninfected Children: A Multicenter Trial of the
                     AIDS Clinical Trials Group
                     A Pharmacokinetic and Tolerance Study of Oral
                     Ganciclovir in HIV-infected Children with
                                                                       Closed to Follow
PACTG     ACTG 226   Asymptomatic Cytomegalovirus Infection and                         41,649   Inactive    Yes          N/A
                                                                       Up
                     Low CD4 Cell Counts or Quiescent
                     Cytomegalovirus Disease
                     Phase I Safety and Pharmacokinetics Study of
PACTG     ACTG 227   Atovaquone (566C80) in HIV-Infected Infants       POS PAC         41,828    Withdrawn   Yes          N/A
                     and Children

                     A Phase I Study to Evaluate the Safety and
                                                                      Closed to Follow
PACTG     ACTG 230   Immunogenicity of Recombinant HIV-1 Envelope                      BB4714    Terminated Yes           N/A
                                                                      Up
                     Antigen in Children Born to HIV Infected Mothers


                     Active Immunization of HIV-Infected Pregnant
PACTG     ACTG 233   Women: A Phase I Study of Safety and              Withdrawn       BB5220    Withdrawn   Yes          N/A
                     Immunogenicity of a rgp120/HIV-1 Vaccine

                     Active Immunization of Asymptomatic HIV-
                     infected Pregnant Women: A Phase I Study of
PACTG     ACTG 234                                                     POS PAC         BB2775    Terminated Yes           N/A
                     Safety and Immunogenicity of
                     VaxsynRecombinant gp160




                                                                       67
                                              PACTG IND studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the IND Status
             Study                                                                        IND
Network                                  Full Title                         Status               IND Status list on the   Change
            Number                                                                      Number
                                                                                                            RCC Website Date
                                                                                                            (Yes/No)

                     Active Immunization of HIV-1 Infected, Pregnant
                     Women, with CD4 Lymphocyte Counts >/=
PACTG     ACTG 235                                                   POS PAC           BB4705    Terminated Yes           N/A
                     400/mm3: A Phase 1 Study of Safety and
                     Immunogenicity of MN rgp120/HIV-1 Vaccine

                     A Phase I Evaluation of the Safety and Toxicity
                     of ZDV and DDI in Combination in HIV-Infected
PACTG     ACTG 239   or Exposed Infants, and a Phase II Study of the POS PAC           35,208    Inactive    Yes          N/A
                     Effect of DDI Alone Vs. ZDV/DDI Combo on HIV
                     RNA in Infants with HIV Infect

                     A Randomized Comparative Trial of Zidovudine
PACTG     ACTG 240   (ZDV) Versus 2'3'-Didehydro-3'-Deoxythymidine POS PAC             43,550    Withdrawn   Yes          N/A
                     (d4T) in Children with HIV Infection

                     A Comparative Study of Combination
PACTG     ACTG 245   Antiretroviral Therapy in Children and            POS PAC         42,003    Inactive    Yes          N/A
                     Adolescents with Advanced HIV Disease

                     A Phase I Trial to Evaluate Didanosine (ddI) in   Closed to Follow
PACTG     ACTG 249                                                                      31,945   Inactive    Yes          N/A
                     HIV-1 Infected Pregnant Women                     Up

                     Phase I Study of the Safety and
                     Pharmacokinetics of Nevirapine in HIV-1
PACTG     ACTG 250                                                     POS PAC         42,003    Inactive    Yes          N/A
                     Infected Pregnant Women and Neonates Born
                     to HIV-1 Infected Pregnant Women




                                                                       68
                                              PACTG IND studies, CRF Destruction March 2010



                                                                                                          Was protocol
                                                                                                          posted on the IND Status
             Study                                                                      IND
Network                                 Full Title                         Status              IND Status list on the   Change
            Number                                                                    Number
                                                                                                          RCC Website Date
                                                                                                          (Yes/No)

                     Phase I Trial to Evaluate the Pharmacokinetics,
                     Safety, and Tolerance of Valacyclovir HCl in HIV-
PACTG     ACTG 253                                                     Withdrawn     46,217    Withdrawn   Yes          N/A
                     1 Infected Children with Herpes Simplex
                     Infections or Varicella/Zoster Infections


                     Stage I - A Randomized, Phase II/III, Double
                     Blind, Two-Armed Study of Micronized-
                     Atovaquone and Azithromycin (AT/AZ) as
                     Compared to Trimethoprim-Sulfamethoxazole
                     (TMP/SMX) in the Prevention of Serious
                     Bacterial Infections when Used in Children Aged Closed to Follow
PACTG     ACTG 254                                                                    46,238   Inactive    Yes          N/A
                     3 Months to 19 Years with HIV Infection;        Up
                     Stage II - A Randomized Study to Evaluate the
                     Safety and Tolerance of Micronized-Atovaquone
                     and Azithromycin (AT/AZ) as Compared to
                     Trimethoprim-Sulfamethoxazole (TMP/SMX) in
                     HIV Infected Children Aged 3 Month to 18 mont


                     A Phase I/II Study of HIVIG in Slowing
PACTG     ACTG 273                                                   POS PAC         BB6159    Terminated Yes           N/A
                     Progression of Disease in HIV-Infected Children


                     A Phase I Study of Combination Therapy with
PACTG     ACTG 274   Didanosine (ddI) and Ribavirin in HIV-Infected   POS PAC        48,739    Inactive    Yes          N/A
                     Children




                                                                      69
                                              PACTG IND studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the IND Status
             Study                                                                      IND
Network                                 Full Title                         Status                IND Status list on the   Change
            Number                                                                    Number
                                                                                                            RCC Website Date
                                                                                                            (Yes/No)

                      A Phase I Trial of the Safety and Immunogenicity
                      of MN rsgp120/HIV-1 with QS-21 Compared to
PACTG     ACTG 279                                                     Withdrawn     BB5747      Terminated Yes           N/A
                      QS-21 Alone in Infants Born to HIV-infected
                      Mothers

PACTG     ACTG 288    Follow-up of Women Participating in ACTG 076 POS PAC           28,972      Inactive    Yes          N/A

                      A Double Blind, Placebo Controlled Trial of the
                      Safety and Immunogenicity of a Seven Valent     Closed to Follow
PACTG     ACTG 292                                                                     BB 6210   Withdrawn   Yes          N/A
                      Pneumococcal Conjugate Vaccine in Presumed Up
                      HIV-Infected Infants

                      A Randomized Comparative Study of Combined
                      Zidovudine-Lamivudine (3TC) vs. the Better of
PACTG     ACTG 300                                                  POS PAC          47,899      Inactive    Yes          N/A
                      ddI Monotherapy vs. Zidovudine Plus ddI in
                      Symptomatic HIV-1 Infected Children

                      A Phase III Randomized, Double Blinded Study
                      of Nevirapine for the Prevention of Maternal-
PACTG     ACTG 316                                                    POS PAC        42,003      Inactive    Yes          N/A
                      Fetal Transmission in Pregnant HIV-Infected
                      Women
                      A Phase III Randomized, Double Blinded Study
                      of Nevirapine for the Prevention of Maternal-
PACTG     ACTG 316A                                                   POS PAC        42,003      Inactive    Yes          N/A
                      Fetal Transmission in Pregnant HIV-Infected
                      Women.
                      A Phase III Randomized, Double Blinded Study
                      of Nevirapine for the Prevention of Maternal-
PACTG     ACTG 316B                                                   POS PAC        42,003      Inactive    Yes          N/A
                      Fetal Transmission in Pregnant HIV-Infected
                      Women.



                                                                      70
                                               PACTG IND studies, CRF Destruction March 2010



                                                                                                               Was protocol
                                                                                                               posted on the IND Status
             Study                                                                           IND
Network                                  Full Title                            Status               IND Status list on the   Change
            Number                                                                         Number
                                                                                                               RCC Website Date
                                                                                                               (Yes/No)

                     Phase I Study of Safety, Tolerance, and
                     Pharmacokinetics of 1592U89 with Standard            Closed to Follow
PACTG     ACTG 321                                                                         52,071   Withdrawn   Yes          N/A
                     Zidovudine (ZDV) Therapy in Neonates Born to         Up
                     HIV-1 Infected Women
                     A Phase I Trial of the Pharmacokinetics and
                     Tolerance of Oral Zidovudine Administered to         Closed to Follow
PACTG     ACTG 324                                                                         28,972   Inactive    Yes          N/A
                     HIV-1 Infected Pregnant Women During Labor           Up
                     and Delivery
                     Trial of Stavudine (d4T) Plus Didanosine (ddI) in
                     Children On Long-Term d4T Monotherapy, and
                     d4T vs. d4T + ddI in Children on Long-Term
PACTG     ACTG 327                                                        POS PAC         47,711    Withdrawn   Yes          N/A
                     ZDV Monotherapy: Rollover Protocol for ACTG
                     240 Participants and Children Receiving
                     Prescription ZDV
                     A Phase I Safety and Pharmacokinetic Study of
                     1592U89 Alone and in Combination with Other
PACTG     ACTG 330                                                        POS PAC         52,071    Withdrawn   Yes          N/A
                     Antiretroviral Agents in Infants and Children with
                     HIV Infection
                     The Safety, Tolerance and Pharmacokinetics of Closed to Follow
PACTG     ACTG 331                                                                  28,972          Inactive    Yes          N/A
                     Zidovudine in Premature Infants Exposed to HIV Up

                     A Phase I/II Open Label Study to evaluate the
                     safety. Tolerance and Pharmacokinetics of
                                                                          Closed to Follow
PACTG     ACTG 332   Stavudine (d4T) in Combination With                                   52,077   Inactive    Yes          N/A
                                                                          Up
                     Lamivudine (3TC) in HIV-1 Infected Pregnant
                     Women and Their Infants.




                                                                          71
                                               PACTG IND studies, CRF Destruction March 2010



                                                                                                             Was protocol
                                                                                                             posted on the IND Status
             Study                                                                         IND
Network                                  Full Title                          Status               IND Status list on the   Change
            Number                                                                       Number
                                                                                                             RCC Website Date
                                                                                                             (Yes/No)


                     A Phase II Rolling Arm Master Protocol (PRAM)
PACTG     ACTG 338   of Novel Anti-Retroviral Therapy in Stable    POS PAC              52,077    Inactive   Yes           N/A
                     Experienced HIV-Infected Children.

                     A Phase I/II Study of Cidofovir for HIV-Infected
PACTG     ACTG 352                                                      Withdrawn       53,534    Inactive   Yes           N/A
                     Children with Invasive CMV Disease
                     A Phase I/II Master Protocol of Novel
                     Antiretroviral Combination Therapies in          Closed to Follow
PACTG     ACTG 366                                                                     55,516     Inactive   Yes           N/A
                     Antiretroviral Experienced Children with Rapidly Up
                     Progessing or Advanced HIV Disease (RAD).
                     A Phase I/II Randomized, Multicenter Protocol
                     Comparing Four Antiretroviral Regimens             Closed to Follow
PACTG     ACTG 377                                                                       54,291   Inactive   Yes           N/A
                     Containing Combinations of Protease Inhibitors,    Up
                     NRTIs and an NNRTI
                     A Phase I Trial of the Safety and
                     Pharmacokinetics of Fortovase (Saquinivir) Co-
                     Administered with Low Dose Ritonavir, ZDV and      Closed to Follow
PACTG     ACTG 386                                                                       56,072   Inactive   Yes           N/A
                     3TC in HIV- Seropositive Pregnant Women            Up
                     During Gestation and PostPartum, and in their
                     Infants Post - Maternal Dosing.
                     A Multicenter, Open-Label, 48 Week Study to
                     Investigate the Safety, Pharmacokinetics, and
PACTG     ACTG 395   Efficacy of Indinavir in Combination with          POS PAC         55,433    Inactive   Yes           N/A
                     Stavudine and Lamivudine in Pediatric Patients
                     with HIV-1 Infection.
                     Randomized Trial of Two Saquinavir-Containing
                                                                        Closed to Follow
PACTG     ACTG 397   Combination Treatment Regimens in Children                          56,603   Inactive   Yes           N/A
                                                                        Up
                     with HIV Infection.




                                                                        72
                                               PACTG IND studies, CRF Destruction March 2010



                                                                                                               Was protocol
                                                                                                               posted on the IND Status
             Study                                                                           IND
Network                                  Full Title                            Status               IND Status list on the   Change
            Number                                                                         Number
                                                                                                               RCC Website Date
                                                                                                               (Yes/No)

                     Randomized, Multicenter Protocol Evaluating
                     Two Antiretroviral Regimens Containing               Closed to Follow
PACTG     ACTG 403                                                                         57,831   Inactive   Yes           N/A
                     Combinations of Protease Inhibitors, NRTIs and       Up
                     NNRTI <PRAM 3>.
                     ACTG 843 is the Virology Substudy of ACTG
                     300. This substudy will attempt to corolate
PACTG     ACTG 843                                                        POS PAC         47,899    Inactive   Yes           N/A
                     disease progression with drug resistance in a
                     subset of ACTG 300 subjects.
                     A substudy of ACTG 254: PK Interaction Study         Closed to Follow
PACTG     ACTG 954                                                                         46,238   Inactive   Yes           N/A
                     for ACTG 254                                         Up
                     A Phase I/II Study of T-20, A Fusion Inhibitor, in   Closed to Follow
PACTG     P1005                                                                            58,681   Inactive   Yes           N/A
                     HIV-1 Infected Children.                             Up
                     High-Dose Multi-Drug Antiretroviral Salvage
                                                                          Closed to Follow
PACTG     P1007      Therapy for Heavily Pretreated End Stage                              58,544   Inactive   Yes           N/A
                                                                          Up
                     Patients - A Phase I Proof of Concept Trial.
                     A Randomized, Open-label, Dose-Finding Study
                     with Serostim, Mammalian Cell-Derived                Closed to Follow
PACTG     P1011                                                                            60,059   Inactive   Yes           N/A
                     Recombinant Human Growth Hormone in                  Up
                     Children with HIV-Associated Growth Failure.
                     Safety, Tolerability, and Antiviral
                                                                          Closed to Follow
PACTG     P1017      Pharmacodynamics of PEG-Intron in HIV-1                               BB9197   Inactive   Yes           N/A
                                                                          Up
                     Infected Children.
                     Single Dose Pharmacokinetic Study of Abacavir
PACTG     P1018                                                    Concluded              61,730    Inactive   Yes           N/A
                     in HIV-Infected Children and Adolescents




                                                                          73
                                              PACTG IND studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the IND Status
             Study                                                                        IND
Network                                 Full Title                          Status               IND Status list on the   Change
            Number                                                                      Number
                                                                                                            RCC Website Date
                                                                                                            (Yes/No)

                     A Randomized Study to Assess the Safety and
                     Efficacy of Early vs. Delayed HAART in HIV
PACTG     P1048                                                        Withdrawn       ??-P1048 Withdrawn   Yes           N/A
                     Infected Infants < 6 months of Age on Disease
                     Outcome at 1-5 Years of Age.

                     A Phase I/II Study to Evaluate the Safety and
                     Immunogenicity of ALVAC HIV Vaccines Alone        Closed to Follow
PACTG     ACTG 326                                                                      BB7187   Inactive   Yes           N/A
                     and with AIDSVAX B/B in Children Born to HIV-     Up
                     Infected Mothers
                     A Phase I Trial of the Safety, Tolerance and
                     Pharmacokinetics of Oral Nelfinavir (Viracept)
                                                                       Closed to Follow
PACTG     ACTG 353   Co-Administered with Zidovudine (ZDV) and                          53,873   Inactive   Yes           N/A
                                                                       Up
                     Lamivudine (3TC) in HIV Infected Pregnant
                     Women and Their Infants.
                     Early Intensive Antiretroviral Combination        Closed to Follow
PACTG     ACTG 356                                                                      52,833   Inactive   Yes           N/A
                     Therapy in HIV-1 Infected Infants and Children.   Up

                     A Phase I Trial of the Safety, Tolerance and
                     Pharmacokinetics of Oral Indinavir Co-
                     Administered with Lamivudine (3TC) and       Closed to Follow
PACTG     ACTG 358                                                                 49,458        Inactive   Yes           N/A
                     Zidovudine (ZDV) in HIV-1 Infected Pregnant  Up
                     Women During Gestation and Post Partum, and
                     in their Infants Post Maternal Dosing.
                     A Phase I/II, Open-Label, AUC-Controlled Study
                     to Determine the Pharmacokinetics, Safety,
                                                                     Closed to Follow
PACTG     ACTG 382   Tolerability, and Antiviral Activity of DMP 266                  53,360     Inactive   Yes           N/A
                                                                     Up
                     (Efavirenz) in Combination with Nelfinavir in
                     Children



                                                                       74
                                                PACTG IND studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the IND Status
             Study                                                                       IND
Network                                   Full Title                         Status             IND Status list on the   Change
            Number                                                                     Number
                                                                                                           RCC Website Date
                                                                                                           (Yes/No)


                     A Phase I/II Trial of Ritonavir and Indinavir in
PACTG     P1013                                                         Concluded     59,143    Inactive   Yes           N/A
                     Children Failing Other Antiretroviral Therapy

                     A Phase I/II Randomized Trial of the Safety and
                     Immunogenicity of Cold Adapted Influenza        Closed to Follow
PACTG     P1057                                                                       BB 11888 Inactive    Yes           N/A
                     Vaccine (Flumist) In HIV-Infected Children and Up
                     Adolescents
                     A Phase II, Randomized, Open-Label Study to
                     Evaluate the Safety and Effectiveness of Two
                     Antiretroviral Therapeutic Strategies: A Dual PI-
PACTG     P1053      Based HAART Regimen Versus a Multi-NRTI           Concluded      71,450    Inactive   No            04/20/09
                     ART Regimen, in ART-Experienced Children
                     and Youth who Have Experienced Virologic
                     Failure




                                                                        75
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the
                                                                                                                            IND Status
 Network   Study Number                  Full Title                  Status     IND Number     IND Status   list on the RCC
                                                                                                                            Change Date
                                                                                                            Website
                                                                                                            (Yes/No)


                          An Open, Prospective, Multicenter
                          Study of Trimetrexate with Leucovorin
TX         ACTG 039       Rescue for AIDS Patients with PCP and Concluded       30,006       Withdrawn      Yes            N/A
                          Serious Intolerance to Approved
                          Therapies


                          A Prospective, Randomized, Open-
                          Label Clinical Trial to Evaluate the
                          Comparative Efficacy and Safety of a
AIEDRP     AI-03-001      Potent Antiretroviral Treatment Regimen Withdrawn     60,069       Withdrawn      Yes            N/A
                          with or without Hydroxyurea for Subjects
                          with Acute HIV-1 Infection or Recent
                          HIV-1 Seroconversion

                          Tenofovir, Emtricitabine, and Nevirapine
                          and Recently HIV-Infected Subjects:
AIEDRP     AI-08-005      Can Short-Course, Once Daily Therapy Withdrawn        70,073       Withdrawn      Yes            N/A
                          Reduce the Viral Load at 12 Months
                          From Estimated Date of Infection


                          A Phase I, Multicenter, Randomized,
                          Double Blind Trial to Evaluate the Safety
AVEG       AVEG 002       and Immunogenicity of Recombinant         Concluded   BB2957       Terminated     Yes            N/A
                          Vaccinia Virus Expressing the Envelope
                          Glycoproteins of HIV




                                                                      76
                                   Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                         Was protocol
                                                                                                         posted on the
                                                                                                                         IND Status
Network   Study Number                 Full Title                 Status     IND Number     IND Status   list on the RCC
                                                                                                                         Change Date
                                                                                                         Website
                                                                                                         (Yes/No)


                         Phase I Safety and Immunogenicity Trial
                         of Vaccinia-HIV Envelope Recombinant
AVEG      AVEG 002A      Vaccine (HIVAC-1e) in Combination       Concluded   BB2957       Terminated     Yes            N/A
                         With Soluble Recombinant Envelope
                         Vaccine (VaxSyn)


                         A Phase I Randomized Trial to Evaluate
                         the Safety and Immunogenicity of
                         Vaccinia-HIV Envelope Recombinant
AVEG      AVEG 002B                                             Concluded    BB2957       Terminated     Yes            N/A
                         Vaccine (HIVAC-1e) in Combination
                         With Soluble Recombinant Envelope
                         Vaccine (VaxSyn)

                         Safety and Immunogenicity of HIV-1
AVEG      AVEG 003       Recombinant Envelope Glycoprotein     Concluded     BB2775       Terminated     Yes            N/A
                         gp160 Vaccine

                         Safety and Immunogenicity of HIV-1
AVEG      AVEG 003A      Recombinant Envelope Glycoprotein     Concluded     BB2775       Terminated     Yes            N/A
                         gp160 Vaccine

                         Safety and Immunogenicity of HIV-I
AVEG      AVEG 003B      Recombinant Envelope Glycoprotein     Concluded     BB2775       Terminated     Yes            N/A
                         gp160 Vaccine




                                                                    77
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the
                                                                                                                            IND Status
Network   Study Number                   Full Title                   Status    IND Number     IND Status   list on the RCC
                                                                                                                            Change Date
                                                                                                            Website
                                                                                                            (Yes/No)


                         A Phase I Multicenter Clinical Trial to
                         Evaluate the Safety and Immunogenicity
AVEG      AVEG 004       of Vaccinia Derived HIV-1 Recombinant Concluded        BB 3671      Withdrawn      Yes            N/A
                         Envelope Glycoprotein (GP160) of
                         Human Immunodeficiency Virus


                         A Phase I Clinical Trial to Evaluate the
                         Safety and Immunogenicity of Vaccinia
AVEG      AVEG 004A      Derived HIV-1 Recombinant Envelope         Concluded   BB 3671      Withdrawn      Yes            N/A
                         Glycoprotein (GP160) of Human
                         Immunodeficiency Virus


                         A Phase I Multicenter Trial to Evaluate
                         the Safety and Immunogenicity of
AVEG      AVEG 004B      Vacciula Derived HIV-1 Recombinant         Concluded   BB 3671      Withdrawn      Yes            N/A
                         Envelope Glycoprotein (gp 160) of
                         Human Immunodeficiency Virus

                         A Phase I Clinical Trial to Evaluate the
AVEG      AVEG 005A      Safety of MTP-PE/MF59 Adjuvant             Concluded   BB 3772      Withdrawn      Yes            N/A
                         Emulsion

                         A Phase I Clinical Trial to Evaluate the
                         Safety and Immunogenicity of ENV 2-3,
                         A Yeast Derived Recombinant Envelope
AVEG      AVEG 005B                                               Concluded     BB 3772      Withdrawn      Yes            N/A
                         Protein of Human Immunodeficiency
                         Virus-1, in Combination with MTP-
                         PE/MF59



                                                                       78
                                    Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                          Was protocol
                                                                                                          posted on the
                                                                                                                          IND Status
Network   Study Number                  Full Title                  Status    IND Number     IND Status   list on the RCC
                                                                                                                          Change Date
                                                                                                          Website
                                                                                                          (Yes/No)

                         A Phase I Clinical Trial to Evaluate: A -
                         The Safety of the MTP-PE/MF 59
AVEG      AVEG 005C      Adjuvant Emulsion; and, B - Safety and Concluded     BB 3772      Withdrawn      Yes            N/A
                         Immunogenicity of Env 2-3 in
                         Combination with MTP/PE/MF59

                         A Phase I, Safety and Immunogenicity
                         Trial of Genentech MN rgp120 in HIV-
AVEG      AVEG 006X      Uninfected Volunteers Who have           Concluded   BB5359       Terminated     Yes            N/A
                         Previously Received Vaccinations with
                         MN rgp120 and/or IIIB rgp120

                         A Phase I, Multicenter, Randomized
                         Trial to Evaluate the Safety and
                         Immunogenicity of Recombinant
AVEG      AVEG 008       Vaccinia-HIV Envelope Vaccine (HIVAC- Concluded      BB2957       Terminated     Yes            N/A
                         1e) in Combination with a Panel of
                         Subunit Recombinant HIV Envelope
                         Vaccines

                         A Phase I, Multicenter Study of the
                         Safety and Immunogenicity of MN
                         rgp120/HIV-1 Vaccine Given Either
AVEG      AVEG 009X                                               Concluded   BB5313       Terminated     Yes            N/A
                         Alone or in Combination with IIIB
                         rgp120/HIV-1 Vaccine in Healthy, Adult
                         Subjects




                                                                     79
                                   Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                        Was protocol
                                                                                                        posted on the
                                                                                                                        IND Status
Network   Study Number                 Full Title                 Status    IND Number     IND Status   list on the RCC
                                                                                                                        Change Date
                                                                                                        Website
                                                                                                        (Yes/No)


                         A Multicenter, Randomized Trial to
                         Evaluate the Safety and Immunogenicity
                         of a Recombinant Vaccinia-HIV
AVEG      AVEG 010       Envelope Vaccine (HIVAC1-e) in         Concluded   BB2957       Terminated     Yes            N/A
                         Combination with a Group of Subunit
                         Recombinant HIV Envelope Vaccines in
                         Vaccinia-Naive Individuals

                         A Phase I Safety and Immunogenicity
                         Trial of Live Recombinant Canarypox-
AVEG      AVEG 012A      gp160 MN (ALVAC vCP125, HIV-1          Concluded   BB5397       Withdrawn      Yes            N/A
                         gp160 MN) in HIV-1-Uninfected Adult
                         Volunteers
                         A Phase I Safety and Immunogenicity
                         Trial of Live Recombinant Canarypox-
AVEG      AVEG 012B      gp160 MN (ALVAC vCP125, HIV-1          Concluded   BB5397       Withdrawn      Yes            N/A
                         gp160 MN) in HIV-1 Uninfected Adult
                         Volunteers

                         A Phase I, Safety and Immunogenicity
                         Trial of Live Recombinant Canarypox-
AVEG      AVEG 012X                                             Concluded   BB5397       Withdrawn      Yes            N/A
                         gp160 MN (ALVAC vCP125, HIV-1
                         gp160 MN) in HIV-1-Uninfected Adults




                                                                   80
                                    Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the
                                                                                                                           IND Status
Network   Study Number                  Full Title                  Status     IND Number     IND Status   list on the RCC
                                                                                                                           Change Date
                                                                                                           Website
                                                                                                           (Yes/No)

                         A Phase I, Multicenter, Randomized
                         Trial to Evaluate the Safety and
                         Immunogenicity of Vaccinia-Derived MN
AVEG      AVEG 013A      and IIIB HIV-1rgp160 of HIV Alone and Concluded       BB4949       Terminated     Yes            N/A
                         in Combination with Vaccinia-HIV
                         Envelope Recombinant Vaccine (HIVAC-
                         1e)
                         A Phase I, Multicenter, Clinical Trial to
                         Evaluate the Safety and Immunogenicity
                         of Vaccinia-Derived MN HIV-1
AVEG      AVEG 013B                                                Concluded   BB4949       Terminated     Yes            N/A
                         Recombinant Envelope Glycoprotein
                         (rgp160) of HIV at Two Different
                         Vaccination Schedules

                         A Multicenter, Randomized, Placebo-
                         Controlled, Double-Blind Trial to
AVEG      AVEG 014A      Evaluate the Safety and Immunogenicity Concluded      BB4930       Terminated     Yes            N/A
                         of a Recombinant Vaccinia-HIV
                         env/gag/pol Vaccine (TBC-3B)

                         A Multicenter, Randomized, Placebo-
                         Controlled, Double-Blind Trial to
AVEG      AVEG 014B      Evaluate the Safety and Immunogenicity Withdrawn      BB4930       Terminated     Yes            N/A
                         of a Recombinant Vaccinia-HIV
                         env/gag/pol Vaccine (TBC-3B)




                                                                     81
                                    Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                          Was protocol
                                                                                                          posted on the
                                                                                                                          IND Status
Network   Study Number                 Full Title                  Status     IND Number     IND Status   list on the RCC
                                                                                                                          Change Date
                                                                                                          Website
                                                                                                          (Yes/No)

                         A Multicenter, Randomized, Placebo-
                         Controlled, Double-Blind Trial to
                         Evaluate the Safety and Immunogenicity
AVEG      AVEG 014C      of the Therion Recombinant Vaccinia    Concluded     BB6957       Terminated     Yes            N/A
                         HIV-1- IIIB env/gag/pol Vaccine (TBC-
                         3B) and MN rgp120/HIV-1 in Alum
                         (VaxGen, Inc.)
                         A Phase I, Randomized, Double-Blind,
                         Placebo-Controlled, Clinical Trial to
                         Compare the Safety and
                         Immunogenicity of Recombinant
AVEG      AVEG 015                                              Concluded     BB5013       Withdrawn      Yes            N/A
                         Envelope Protein, SF-2 rgp120/HIV-
                         1(BIOCINE), Individually Combined with
                         Seven Adjuvants, in Healthy HIV-1
                         Uninfected Indivi...
                         A Phase I, Multicenter, Randomized,
                         Double-Blind, Placebo-Controlled HIV-1
                         Vaccine Trial to Evaluate the Safety and
AVEG      AVEG 016                                                Concluded   BB5045       Terminated     Yes            N/A
                         Immunogenciity of MN rsgr120/HIV-1
                         (Genentech) in Combination with QS21
                         Adjuvant and/or Alum in Healthy Adults

                         A Phase I, Multicenter, Randomized,
                         Double-Blind, Placebo-Controlled HIV-1
                         Vaccine Trial to Evaluate the Safety and
AVEG      AVEG 016A                                               Concluded   BB5045       Terminated     Yes            N/A
                         Immunogenicity of MN rsgp120/HIV-1
                         [Genentech] in Combination with QS21
                         Adjuvant and/or Alum in Healthy Adults




                                                                    82
                                    Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                          Was protocol
                                                                                                          posted on the
                                                                                                                          IND Status
Network   Study Number                 Full Title                  Status     IND Number     IND Status   list on the RCC
                                                                                                                          Change Date
                                                                                                          Website
                                                                                                          (Yes/No)

                         A Phase I, Multicenter, Randomized,
                         Double-Blind, Placebo-Controlled HIV-1
                         Vaccine Trial to Evaluate the Safety and
AVEG      AVEG 016B      Immunogenicity of Low Dose MN            Concluded   BB5045       Terminated     Yes            N/A
                         RSGP120/HIV-1 [Genentech] in
                         Combination with QS21 Adjuvant or
                         Alum in Healthy Adults
                         A Phase I, Safety and Immunogenicity
AVEG      AVEG 019       Study of HIV p17/p24:Ty-VLP in HIV-1   Concluded     BB 5630      Withdrawn      Yes            N/A
                         Seronegative Subjects
                         A Phase I Safety and Immunogenicity
                         Trial of Polyvalent T1-SP10(A) HIV-1
AVEG      AVEG 020       gp160-Derived Synthetic Peptides        Concluded    BB 7289      Withdrawn      Yes            N/A
                         Mixed in Mineral Oil Containing
                         Mannose Mono-Oleate
                         A Phase I Safety and Immunogenicity
                         Trial of Live Recombinant Canarypox
AVEG      AVEG 022                                               Concluded    BB5901       Inactive       Yes            N/A
                         ALVAC-MN120TMG (vCP205) in HIV-1
                         Uninfected Adult Volunteers
                         A Phase I Safety and Immunogenicity
                         Trial of Live Recombinant Canarypox
AVEG      AVEG 022A      ALVAC-MN120TMG (vCP205) and HIV- Concluded           BB5901       Inactive       Yes            N/A
                         1 SF-2 rgp120 in HIV-1-Uninfected Adult
                         Volulnteers




                                                                    83
                                   Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                         Was protocol
                                                                                                         posted on the
                                                                                                                         IND Status
Network   Study Number                 Full Title                 Status     IND Number     IND Status   list on the RCC
                                                                                                                         Change Date
                                                                                                         Website
                                                                                                         (Yes/No)

                         A Randomized, Placebo-Controlled,
                         Double-Blinded, Phase I, Safety and
                         Immunogenicity Trial of Recombinant
AVEG      AVEG 024                                              Concluded    BB5013       Withdrawn      Yes            N/A
                         Envelope Protein, HIV-1 SF-2 rgp120
                         (Biocine) Combined with MF59 in HIV-1-
                         Uninfected Adult Volunteers

                         A Multicenter, Randomized, Placebo-
                         Controlled, Double-Blind Trial to
AVEG      AVEG 025                                              Withdrawn    BB6291       Withdrawn      Yes            N/A
                         Evaluate the Safety and Immunogenicity
                         of an HIV-1 Pseudovirion Vaccine

                         A Phase I Safety & Immunogenicity Trial
                         of Live Recombinant Canarypox ALVAC-
AVEG      AVEG 026                                               Concluded   BB6406       Terminated     Yes            N/A
                         HIV (vCP300) and HIV-1 SF-2 rgp120 in
                         HIV-1-Uninfected Adult Volunteers

                         A Randomized Phase I Safety and
                         Immungenicity Trial of Live
                         Recombinant Canarypox ALVAC-HIV
AVEG      AVEG 027                                             Concluded     BB5901       Inactive       Yes            N/A
                         vCP205 Delivered by Alternate Mucosal
                         Routes in HIV-1 Uninfected Adult
                         Volunteers




                                                                    84
                                    Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the
                                                                                                                           IND Status
Network   Study Number                  Full Title                  Status     IND Number     IND Status   list on the RCC
                                                                                                                           Change Date
                                                                                                           Website
                                                                                                           (Yes/No)

                         A Phase I Safety and Immunogenicity
                         Trial of Orally Administered Live
                         Attenuated Recombinant Salmonella
AVEG      AVEG 028       Typhi CVD 908 ^asd Expressing HIV-1 Concluded         BB6963       Terminated     Yes            N/A
                         LAI gp120 (VVG 203) and Parenterally
                         Administered HIV-1 MN rgp120 in Alum
                         in HIV-Uninfect.Volunteer
                         A Phase I Safety & Immunogenicity Trial
                         of Live Recombinant Canarypox ALVAC-
                         HIV (vCP205) and HIV-1 SF-2 rgp120 in
AVEG      AVEG 029                                               Concluded     BB5901       Inactive       Yes            N/A
                         HIV-1-Uninfected Volunteers to
                         Evaluate Accelerated Vaccine
                         Schedules
                         A Phase I Safety and Immunogenicity
                         Trial of the Facilitated HIV-1 gag-pol
                         DNA Vaccine (APL-400-047, Apollon,
AVEG      AVEG 031       Inc.) Given Intramuscularly by Needle    Concluded    BB 6972      Inactive       Yes            N/A
                         and Syringe or Biojector 2000 Needle-
                         Free Jet Injection System in HIV-1
                         Uninfected Adult Vol.

                         A Phase I Trial to Evaluate the HIV-1 SF-
                         2 Recombinant p24 Subunit Vaccine
                         (Chiron Vaccines) Administered as a
                         Novel Boost in "Prime Boost"
AVEG      AVEG 032                                                 Concluded   BB8353       Inactive       Yes            N/A
                         Vaccination Regimens With ALVAC-HIV
                         vCP205 (Pasteur Merieux Connaught)
                         and HIV-1 SF-2 rgp120 in MF59 (Chiron
                         Vacc)



                                                                     85
                                    Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the
                                                                                                                           IND Status
Network   Study Number                   Full Title                  Status    IND Number     IND Status   list on the RCC
                                                                                                                           Change Date
                                                                                                           Website
                                                                                                           (Yes/No)

                         A Multicenter, Randomized, Placebo-
                         Controlled Trial to Evaluate the Safety
                         and Immunogenicity of Live
AVEG      AVEG 033                                                 Concluded   BB7318       Inactive       Yes            N/A
                         Recombinant Canarypox ALVAC-HIV
                         vCP205 Combined with GM-CSF in
                         Healthy, HIV-1 Uninfected Volunteers
                         A Phase I Trial to Compare the Safety
                         and Immunogenicity of Three Live
                         Recombinant Canarypx ALVAC-HIV
AVEG      AVEG 034       Vaccines (VCP205, VCP1433 and          Concluded      BB7702       Inactive       Yes            N/A
                         VCP1452) with HIV-1 MN GP120/LAI-2
                         GP41 (RGP160)Vaccine in Alum in HIV-
                         1 Uninfected Adult Volunteers
                         A Phase I, Multicenter, Randomized,
                         Double-Blind, Placebo-Controlled Trial
                         toEvaluate the Safety and
                         Immunogenicity of HIV-1 MN rsgp120
AVEG      AVEG 036                                              Concluded      BB7811       Inactive       Yes            N/A
                         and Bivalent AIDSVAX B/E (HIV-1 MN
                         rgp120/A244 rgp120) in Combination
                         with QS-21 with or without Alum in
                         Healthy HIV-1
                         A Multi-Centered Phase 1 Trial to
                         Evaluate the Memory Responses to a
                         Single Boosting Vaccination with ALVAC-
AVEG      AVEG 038                                               Concluded     BB 8810      Withdrawn      Yes            N/A
                         HIV vCP205 in Volunteers Who Have
                         Previously Received Poxvirus-Based
                         Vaccines




                                                                      86
                                    Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the
                                                                                                                           IND Status
Network   Study Number                  Full Title                  Status     IND Number     IND Status   list on the RCC
                                                                                                                           Change Date
                                                                                                           Website
                                                                                                           (Yes/No)

                         A Phase I Mulitcenter Clinical Trial to
                         Evaluate the Safety and Immunogenicity
AVEG      AVEG 101       of Immuno-AG Recombinant HIV (GP        Concluded     BB 3671      Withdrawn      Yes            N/A
                         160) in Asymptomatic HIV Seropositive
                         Volunteers
                         Active Immunization of Asymptomatic,
                         HIV-Infected, Pregnant Women: A
AVEG      AVEG 102       Phase I Study of Safety and               Concluded   BB2775       Terminated     Yes            N/A
                         Immunogenicity of VaxSyn
                         Recombinant gp160
                         A Placebo Controlled, Phase I, Pilot,
                         Clinical Trial to Evaluate the Safety and
                         Immunogenicity of ENV 2-3 (A Yeast
AVEG      AVEG 103       Derivative Recombinant Envelope           Concluded   BB 3772      Withdrawn      Yes            N/A
                         Protein of HIV-1) in Combination with
                         MTP-PE/MF59 in Individuals with HIV
                         Infection
                         A Placebo Controlled, Phase I, Pilot,
                         Clinical Trial to Evaluate the Safety and
                         Immunogenicity of ENV 2-3 (A Yeast
AVEG      AVEG 103A      Derivative Recombinant Envelope           Concluded   BB 3772      Withdrawn      Yes            N/A
                         Protein of HIV-1) in Combination with
                         MTP-PE/MF59 in Individuals with HIV
                         Infection




                                                                     87
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                             Was protocol
                                                                                                             posted on the
                                                                                                                             IND Status
Network   Study Number                   Full Title                    Status    IND Number     IND Status   list on the RCC
                                                                                                                             Change Date
                                                                                                             Website
                                                                                                             (Yes/No)

                         A Placebo Controlled, Phase I, Pilot,
                         Clinical Trial to Evaluate the Safety and
                         Immunogenicity of ENV 2-3 (A Yeast
AVEG      AVEG 103B      Derivative Recombinant Envelope           Concluded     BB 3772      Withdrawn      Yes            N/A
                         Protein of HIV-1) in Combination with
                         MTP-PE/MF59 in Individuals with HIV
                         Infection
                         Active Immunization of HIV-1 Infected,
                         Pregnant Women, with CD4
                         Lymphocyte Counts >/= 400/mm3: A
AVEG      AVEG 104                                                 Concluded     BB4705       Terminated     Yes            N/A
                         Phase 1 Study of Safety and
                         Immunogenicity of MN rgp120/HIV-1
                         Vaccine
                         A Phase II Trial to Evaluate the
                         Immunogenicity and Reactogenicity of
                         the Recombinant Subunit HIV-1
AVEG      AVEG 201       Envelope Vaccines SF-2 rgp120             Concluded     BB4714       Terminated     Yes            N/A
                         (Biocine/Chiron) in MF59 and MN
                         rgp120 (Genentech) in Alum in High
                         Risk Populations
                         A Phase II Safety and Immunogenicity
                         Trial of Live Recombinant Canarypox
AVEG      AVEG 202       ALVAC-HIV vCP205 with or without HIV- Concluded         BB5901       Inactive       Yes            N/A
                         1 SF-2 rgp120 in HIV-1 Uninfected Adult
                         Volunteers
                         A Phase II Clinical Trial to Evaluate the
                         Immunogenicityand Safety of a
AVEG      AVEG 203       Combined Regimen Using ALVAC                Withdrawn   BB8987       Inactive       Yes            N/A
                         vCP1452 and AIDSVAX B/B, B/E, or
                         MNrgp120


                                                                        88
                                      Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the
                                                                                                                            IND Status
 Network   Study Number                   Full Title                  Status    IND Number     IND Status   list on the RCC
                                                                                                                            Change Date
                                                                                                            Website
                                                                                                            (Yes/No)

                          Open-Label, Multi-Site Study for the
                          Administration of Vaccinia Immune
                          Globulin (Human) to Subjects Who
AVEG       AVEG 801       Experience Complications from Vaccinia Withdrawn      BB 8710      Withdrawn      Yes            N/A
                          Virus Vaccinations or to Unprotected
                          Individuals Accidentally Exposed to
                          Vaccinia Virus or Related Orthopox Viru
                          Evaluation of the Safety, Tolerance, and
                          Pharmacokinetics of
DATRI      DATRI 001      Rifabutin/Clarithromycin Combination     Concluded    39,069       Inactive       Yes            N/A
                          and Rifabutin/Azithromycin Combination
                          in HIV-infected Patients
                          Pilot Study to Evaluate the Efficacy of
                          Zidovudine in Preventing CD4+
DATRI      DATRI 002                                                Concluded   28,972       Inactive       Yes            N/A
                          Lymphocyte Decline in Patients with
                          Primary HIV Infection

                          A Multicenter, Open-label Study of Viral
                          Burden in Peripheral Blood vs.
DATRI      DATRI 003      Lymphoid Tissue Before and After         Concluded    35,208       Inactive       Yes            N/A
                          Antiretroviral Therapy in HIV-Infected
                          Individuals without AIDS
                          A Phase I/II Study to Evaluate Single
                          Agent and Combination Therapy with
DATRI      DATRI 004      Megestrol Acetate and Dronabinol for      Concluded   39,068       Inactive       Yes            N/A
                          the Treatment of HIV-Wasting
                          Syndrome




                                                                       89
                                    Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                          Was protocol
                                                                                                          posted on the
                                                                                                                          IND Status
 Network   Study Number                 Full Title                 Status     IND Number     IND Status   list on the RCC
                                                                                                                          Change Date
                                                                                                          Website
                                                                                                          (Yes/No)

                          Evaluation of the Safety and Tolerance
                          of Immunotherapy with Autologous, Ex-
DATRI      DATRI 006      vivo Expanded, HIV-specific Cytoxic T- Concluded    BB4685       Inactive       Yes            N/A
                          cells in HIV-infected Patients with CD4+
                          Counts Between 100-400/mm3
                          The Effect of Therapy on the Tissue
                          Burden of Disseminated MAC Infection
                          as Measured by Quantitative Bone
DATRI      DATRI 007                                             Concluded    41,772       Inactive       Yes            N/A
                          Marrow Culture and Correlation with
                          Quantitative Blood Culture in HIV-
                          Infected Patients
                          A Pilot Study of Methodology to Rapidly
                          Evaluate Drugs for Bactericidal Activity,
DATRI      DATRI 008      Tolerance and Pharmacokinetics in the Concluded     42,061       Inactive       Yes            N/A
                          Treatment of Pulmonary Tuberculosis
                          Using Isoniazid and Levofloxacin
                          A Phase I Trial of HIV-1 C4-V3
DATRI      DATRI 010      Polyvalent Peptide Vaccine in HIV-1     Concluded   BB6028       Terminated     Yes            N/A
                          Infected Persons
                          A Phase I Study of Methotrexate for HIV
DATRI      DATRI 013                                              Concluded   BB5177       Withdrawn      Yes            N/A
                          Infection
                          ACTG 196/CPCRA 009 Substudy of the
                          Population Pharmacokinetics and
DATRI      DATRI 014                                             Concluded    41,373       Withdrawn      Yes            N/A
                          Pharmacodynamics of Clarithromycin
                          and Rifabutin Alone and in Combination




                                                                     90
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the
                                                                                                                            IND Status
 Network   Study Number                   Full Title                 Status     IND Number     IND Status   list on the RCC
                                                                                                                            Change Date
                                                                                                            Website
                                                                                                            (Yes/No)

                          A Dose Escalation Study to Evaluate
                          Tolerance and Antiviral Effect of Oral
DATRI      DATRI 017                                               Withdrawn    49,055       Withdrawn      Yes            N/A
                          Vitamin C in Two Groups of HIV-
                          Infected Adults
                          Pharmacodynamics and Population
                          Pharmacokinetics of Atovaquone and
DATRI      DATRI 019                                               Concluded    45,799       Withdrawn      Yes            N/A
                          Dapsone used in Prophylaxis against
                          PCP in HIV-infected Patients

                          A Multicenter, Prospective,
                          Randomized, Double-blind, Placebo-
                          controlled Trial of Three Preparations of
DATRI      DATRI 022                                                Concluded   BB 6202      Withdrawn      Yes            N/A
                          Low-dose Oral Alpha Interferon in HIV-
                          infected Patients with CD4+ Counts >/=
                          50 and </= 350 cells/cmm
                          A Phase I Study of Safety And
                          Pharamacokinetics of Nevirapine in HIV-
HNET       HIVNET 006     1 Infected Pregnant Ugandan Women Concluded           49,991       Inactive       Yes            N/A
                          and Neonates born to HIV-1 Infected
                          Ugandan Mothers
                          A Phase I Study of the Safety and
                          Immunogenicity of Live Recombinant       Closed to
HNET       HIVNET 007                                                           BB7069       Terminated     Yes            N/A
                          ALVAC-HIV vCP205 in HIV-1                Accrual
                          Uninfected Adult Volunteers in Uganda




                                                                       91
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the
                                                                                                                           IND Status
 Network   Study Number                  Full Title                 Status     IND Number     IND Status   list on the RCC
                                                                                                                           Change Date
                                                                                                           Website
                                                                                                           (Yes/No)

                          A Phase IIB Trial to Determine the
                          Efficacy of Oral AZT and the Efficacy of
                          Oral Nevirapine for the Prevention of
HNET       HIVNET 012                                              Concluded   49,991       Inactive       Yes            N/A
                          Vertical Transmission of HIV-1 Infection
                          in Pregnant Ugandan Women and Their
                          Neonates
                          Phase II Safety and Immunogenicity
                          Trial of Live Recombinant Canarypox
           HIVNET 014
HNET                      ALVAC-HIV vCP205 with and Without     Concluded      BB5901       Inactive       Yes            N/A
           AVEG 202
                          HIV-1 SF-2 rgp120 in HIV-1 Uninfected
                          Adult Volunteers
                          Phase I/II Study to Assess the Safety
                          and Plasma Concentrations of
                          Nevirapine Given Daily, Twice a Week
HNET       HIVNET 023                                             Concluded    49,991       Inactive       Yes            N/A
                          or Weekly as Prophylaxis in
                          Breastfeeding Infants From Birth to 6
                          Months
                          Intrapartum/newborn nevirapine
HNET       HIVNET 023_1                                           Concluded    49,991       Inactive       Yes            N/A
                          regimen substudy of HIVNET 023

                          Phase III Trial of Antibiotics to Reduce
HPTN       HIVNET 024     Chorioamnionitis-Related Perinatal HIV Concluded     49,991       Inactive       Yes            N/A
                          Transmission
                          A Multisite Phase II Clinical Trial to
           HVTN           Evaluate the Immunogenicity and Safety
HVTN                                                             Concluded     BB 8762      Inactive       Yes            N/A
           (HIVNET) 026   of ALVAC-HIV vCP1452 Alone and
                          Combined with MN rgp120.




                                                                     92
                                      Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                              Was protocol
                                                                                                              posted on the
                                                                                                                              IND Status
 Network   Study Number                   Full Title                    Status    IND Number     IND Status   list on the RCC
                                                                                                                              Change Date
                                                                                                              Website
                                                                                                              (Yes/No)

                          A Phase I Trial to Evaluate the Safety,
                          Tolerability and Immunogenicity of High
                          Dose Live Recombinant Canarypox
HVTN       HVTN 039                                               Concluded       BB 9572      Inactive       Yes            N/A
                          ALVAC-HIV Vaccine (vCP1452) in
                          Healthy, HIV-1 Uninfected Adult
                          Participants
                          A Phase I Safety and Immunogenicity
                          Trial of a Combination Vaccine (NefTat
                          and gp120W61D) Formulated with
HVTN       HVTN 041                                                   Concluded   BB 10104     Inactive       Yes            N/A
                          ASO2A (GlaxoSmithKline Biologicals)
                          Given Intramuscularly in HIV-1
                          Uninfected Adult Participants

                          A Phase I/II Clinical Trial to Evaluate the
                          Safety and Immunogenicity of LIPO-5
                          Alone, ALVAC-HIV (vCP1452) Alone,
HVTN       HVTN 042                                                   POS PAC     BB 11440     Inactive       Yes            N/A
                          and ALVAC HIV Prime / LIPO-5 Boost in
                          Healthy, HIV-1 Uninfected Adult
                          Participants
                          A Phase II Clinical Trial to Evaluate the
                          Immunogenicity and Safety of a
HVTN       HVTN 203                                                   Concluded   BB8987       Inactive       Yes            N/A
                          Combined Regimen Using ALVAC
                          vCP1452 and AIDSVAX B/B
                          Provision of VIG for participant in Pox-
HVTN       HVTN 801                                                   Concluded   BB 8710      Withdrawn      Yes            N/A
                          based Recombinant Vaccine Studies




                                                                         93
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                             Was protocol
                                                                                                             posted on the
                                                                                                                             IND Status
 Network   Study Number                  Full Title                   Status     IND Number     IND Status   list on the RCC
                                                                                                                             Change Date
                                                                                                             Website
                                                                                                             (Yes/No)

                          An Open-Label, Passive Antibody Trial
                          to Assess Efficacy in the Pathogenic
HVTN       HVTN 803       SHIV-89.6P Macaque Model of Human Concluded            BB 10215     Withdrawn      Yes            N/A
                          Antibodies Generated by a Candidate
                          HIV-1 Vaccine in a Phase I Clinical Trial

                          Evaluation of Intravenous Trimetrexate
                          in Combination with Either Low Dose
IRP        IRP 002        Dapsone or Aerosolized Pentamidine as Concluded        31,914       Withdrawn      Yes            N/A
                          Therapy for Previously Untreated PCP
                          in Patients with AIDS (88-CC-197)

                          A Phase I/II Study of GM-CSF in
                          Combination with Zidovudine and Alpha
IRP        IRP 003                                                Concluded      BB3038       Inactive       Yes            N/A
                          Interferon in the Treatment of Patients
                          with HIV Infection (88-I-181)
                          A Phase I Study of Alpha Interferon in
IRP        IRP 004        Combination with Interleukin-2 in        Concluded     BB 3043      Withdrawn      Yes            N/A
                          Patients with HIV Infection (88-I-170)
                          A Pilot Study of the Toxicity and Efficacy
                          of Weekly Dapsoneand Weekly
IRP        IRP 005        Dapsone Plus Pyrimethamine for the         Concluded   32,810       Withdrawn      Yes            N/A
                          Prevention of Pneumocystis carinii
                          Pneumonia in HIV-Infected Patients




                                                                       94
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the
                                                                                                                            IND Status
 Network   Study Number                  Full Title                   Status    IND Number     IND Status   list on the RCC
                                                                                                                            Change Date
                                                                                                            Website
                                                                                                            (Yes/No)

                          A Pilot Study of Pyrimethamine and
                          Dapsone for the Treatment of
IRP        IRP 006                                                Concluded     32,810       Withdrawn      Yes            N/A
                          Toxoplasmosis in Patients Infected with
                          the Human Immunodeficiency Virus

                          A Phase I-II Dose Escalation Study to
                          Evaluate the Safety, Anti-Viral and
                          Immune Enhancing Effects of 3'-Azido-
IRP        IRP 007                                                  Concluded   33,086       Withdrawn      Yes            N/A
                          2',3'-dideoxyuridine (AzdU) in Patients
                          with Human Immunodeficiency Virus
                          Type I (HIV-I) Infection (89-CC-162)

                          Phase I-II Study of the Combination of
                          Dideoxyinosine (ddI) and Interferon-
IRP        IRP 008                                                  Concluded   34,595       Inactive       Yes            N/A
                          alpha in the Treatment of HIV Infection
                          (90-I-110)
                          A Pilot Study to Evaluate the Safety and
                          Efficacy of Foscarnet and ddI with and
                          without Laser Photocoagulation versus
IRP        IRP 009        Ganciclovir and ddI with and without     Withdrawn    34,729       Withdrawn      Yes            N/A
                          Laser Photocoagulation in the
                          Treatment of CMV Retinitis in Patient
                          with AIDS
                          A Phase I/II Study of the Safety and
                          Efficacy of Combined Zidovudine,
                          Interferon-alpha, and Recombinant
IRP        IRP 010                                                 Withdrawn    BB3550       Withdrawn      Yes            N/A
                          Human CD4 Immunoglobulin (rCD4-
                          IgG) Therapy in HIV-Infected Individuals
                          (90-I-114)




                                                                       95
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the
                                                                                                                           IND Status
 Network   Study Number                  Full Title                  Status    IND Number     IND Status   list on the RCC
                                                                                                                           Change Date
                                                                                                           Website
                                                                                                           (Yes/No)

                          An Open Trial Combining ZDV, IFN-
                          alpha, and Recombinant CD4-IgG with
                          Transplantation of Syngeneic Bone
IRP        IRP 011        Marrow and Peripheral Blood            Concluded     BB 3542      Withdrawn      Yes            N/A
                          Lymphocytes from Healthy gp160-
                          Immunized Donors in the TX of Patients
                          with HIV Infection (90-I-76)
                          An Open Trial Combining ddI, IFN-
                          alpha, and Recombinant CD4-IgG with
                          Transplantation of Syngeneic Bone
IRP        IRP 012        Marrow and Peripheral Blood            Concluded     BB 3849      Withdrawn      Yes            N/A
                          Lynphocytes from Healthy gp160-
                          Immunized Donors in the TX of Patients
                          with HIV Infection (90-I-76)
                          A Randomized Trial of L-735,524, an
                          Inhibitor of the Protease Enzyme, and
IRP        IRP 016                                                 Withdrawn   BB6152       Terminated     Yes            N/A
                          Interleukin-2 in Persons Infected with
                          HIV (94-I-202)
                          Effect of Intravenously Administered
                          SCH 52000, rhuIL-10, on Immune
IRP        IRP 017        Function and Viral Replication and Load Concluded    BB 5950      Withdrawn      Yes            N/A
                          in HIV-Positive and HIV-Negative
                          Volunteers (95-I-0125)
                          Subcutaneously Administered
                          Interleukin-12 Therapy in HIV-Infected
IRP        IRP 022        Patients with Disseminated              Concluded    BB 7623      Withdrawn      Yes            N/A
                          Mycobacterium avium Complex
                          Infection (98-I-0091)




                                                                      96
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                            Was protocol
                                                                                                            posted on the
                                                                                                                            IND Status
 Network   Study Number                  Full Title                   Status    IND Number     IND Status   list on the RCC
                                                                                                                            Change Date
                                                                                                            Website
                                                                                                            (Yes/No)

                          A Pilot Study of Once-DailyTherapy with
                          Amprenavir, Ritonavir, Lamivudine and
IRP        IRP 025                                                 Withdrawn    59,411       Withdrawn      Yes            N/A
                          Abacavir in HIV-Infected, Antretroviral-
                          Niave Patients
                          A Piot Study to Evaluate the Ability of
                          the HIV Fusion Inhibitor T-20 to Delay or
IRP        IRP 027                                                  Withdrawn   58,681       Inactive       Yes            N/A
                          Prevent Rebound of Plasma HIV RNA
                          Following an Interruption of HAART.
                          A Study of Trimetrexate with Calcium
                          Leucovorin Rescue for AIDS Patients
NS         NS 401         who are Refractory to Standard            Concluded   30,006       Withdrawn      Yes            N/A
                          Therapies for Pneumocystic carinii
                          Pneumonia
                          An Open Protocol for the Use of AZT for
                          Prophylactic Treatment of Individuals
NS         NS 402                                                   Concluded   28,972       Inactive       Yes            N/A
                          After Accidental Massive Exposure to
                          HIV
                          A Treatment Protocol for the Use of
                          Trimetrexate with Calcium Leucovorin
TX         TX 301         Rescue for AIDS Patients with PCP and     Concluded   30,006       Withdrawn      Yes            N/A
                          Serious Intolerance to Approved
                          Therapies
                          A Treatment Protocol for the Use of
                          Intravenous Ganciclovir in AIDS
TX         TX 303                                                   Concluded   32,350       Withdrawn      Yes            N/A
                          Patients with Immediately Sight-
                          Threatening CMV Retinitis




                                                                       97
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                              Was protocol
                                                                                                              posted on the
                                                                                                                              IND Status
 Network   Study Number                  Full Title                     Status    IND Number     IND Status   list on the RCC
                                                                                                                              Change Date
                                                                                                              Website
                                                                                                              (Yes/No)

                          Evaluation of an HIV-1 DNA Vaccine,
                          pGag(del
VRC        VRC 001        fs)Pol(delta)PR(delta)RT(delta)IN/h,        POS PAC     BB 9782      Inactive       Yes            N/A
                          Encoding a Modified Gag-Pol in
                          Uninfected Adult Volunteers
                          A Phase I Clinical Trial to Evaluate the
                          Safety and Immunogenicity of a
VRC        VRC 202        Multicomponent Ebola DNA Plasmid            Withdrawn   BB 10474     Withdrawn      Yes            N/A
                          Vaccine, VRC-EBODNA007-00-VP, in
                          Adult Volunteers
                          A Phase 1 Clinical Trial to Evaluate the
                          Safety and Immunogenicity of a Multiple
VRC        VRC 204        Strain Ebola DNA Plasmid Vaccine,           Concluded   BB11294      Inactive       Yes            N/A
                          VRC-EBODNA012-00-VP, in Adult
                          Volunteers
                          A Pilot Open-Label Phase II Clinical
                          Trail to Evaluate the Safety and Efficacy
                          of a Compact Three Drug Antiretroviral      Closed to
AIEDRP     AI-03-005                                                              61,118       Inactive       No             04/17/09
                          Treatment Regimen for Subjects with         Follow Up
                          Acute HIV-1 Infection or Recent HIV-1
                          Seroconversion
                          A Phase I Trial to Evaluate the Safety
                          and Immunogenicity of the HIV-1
HVTN'      HVTN 045       pGA2/JS2 Plasmid DNA Vaccine Given          Concluded   BB10494      Inactive       No             08/13/09
                          Intramuscularly (IM) in HIV-1 Uninfected
                          Adults.
                          A Phase I Dose-Escalation Clinical Trial
                          to Evaluate the Safety and
HVTN       HVTN 048       Immunogenicity of the EP HIV-1090           POS PAC     BB10881      Inactive       No             04/13/09
                          DNA Vaccine in Healthy, HIV-1-
                          Uninfected Adult Participants


                                                                          98
                                     Other Network/non Network IND Studies, CRF Destruction March 2010



                                                                                                           Was protocol
                                                                                                           posted on the
                                                                                                                           IND Status
 Network   Study Number                 Full Title                  Status     IND Number     IND Status   list on the RCC
                                                                                                                           Change Date
                                                                                                           Website
                                                                                                           (Yes/No)

                          A Phase I Clinical Trial to Evaluate the
                          Safety and Immunogenicity of a CTL
                          Multi-Epitope Peptide HIV Vaccine
HVTN       HVTN 056                                                Concluded   BB11425      Inactive       No             11/03/09
                          Formulated with RC529-SE, with or
                          without GM-CSF, in Healthy, HIV-1
                          Uninfected Adult Participants
                          A Phase I Clinical Trial to Evaluate the
                          Safety and Immunogenicity of a 6-
VRC        VRC 007        Plasmid Multiclade HIV-1 DNA Vaccine, Concluded      BB11750      Inactive       No             07/29/09
                          VRC-HIVDNA016-00-VP, in Uninfected
                          Adult Volunteers




                                                                     99

								
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