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HEPAVIH Cohort Description Survey Form

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					                                Cohort Description Survey Form


1. Cohort Name, Country/countries:



                             ANRS CO13 HEPAVIH, France




2. Contact details:

 Cohort Representative:
Contact Person:   François DABIS
Address:          INSERM U897/ ISPED
                      Université Bordeaux Segalen, Case 11,
                      146 rue Léo Saignat 33076 Bordeaux cedex France
Phone:                (33) 5 57 57 14 36
Email:                francois.dabis@isped.u-bordeaux2.fr
Website:              http://www.isped.u-bordeaux2.fr

 Data Manager
Contact Person:       Laurence MERCHADOU
Address:              INSERM U897/ ISPED
                      Université Bordeaux Segalen, Case 11,
                      146 rue Léo Saignat 33076 Bordeaux cedex France
Phone:                (33) 5 57 57 45 20
Email:                laurence.merchadou@isped.u-bordeaux2.fr
Website:               http://www.isped.u-bordeaux2.fr




                                                                        Page 1 of 22
3. Cohort Description:

3a. General description
Please indicate the site(s) for recruitment including the site PI and email address. For each site please
also include: 1) number of patients; 2) how many patients are under active follow-up (seen at least
once in 2003 or 2004, even if died since that visit); and 3) whether follow-up visits are also made by
private physicians or "Do patients visit any other physician for their HIV"

                          Site for recruitment                                      PI / email             N° patients

CHU Cochin,                     Médecine Interne et Maladies            Pr Dominique Salmon                    119
Paris                           Infectieuses, Hépatogastroentérologie   dominique.salmon@cch.aphp.fr
CHU Pitié Salpétrière,          Maladies Infectieuses et Tropicales,    Pr Christine Katlama                   171
Paris                           Hépatogastroentérologie                 Christine.Katlama@psl.aphp.fr
CHU Tenon ,                     Maladies Infectieuses et Tropicales     Pr Gilles Pialoux                      93
Paris                                                                   Gilles.Pialoux@tnn.aphp.fr
CHU Avicenne,                   Médecine Interne/ Unité VIH             Dr François Rougès                     42
Bobigny                                                                 francois.rouges@avc.aphp.fr
CHU Bichat-Claude Bernard,      Maladies Infectieuses                   Dr Anne Gervais                        47
Paris                                                                   anne.gervais@bch.aphp.fr
CHU Saint Louis,                Maladies Infectieuses                   Dr Caroline Lascoux-Combe              40
Paris                                                                   caroline.lascoux-
                                                                        combe@sls.aphp.fr
CHU Saint Antoine,              Maladies Infectieuses et Tropicales     Dr Karine Lacombe                      58
Paris                                                                   karine.lacombe@sat.aphp.fr
CHU Bicetre,                    Médecine Interne et Maladies            Pr Cécile Goujard                      13
Paris                           Infectieuses                            cecile.goujard@bct.aphp.fr
CHU Paul Brousse,               Maladies Infectieuses                   Pr Daniel Vittecoq                     20
Paris                                                                   daniel.vittecoq@pbr.aphp.fr
CHU Necker,                     Maladies Infectieuses et Tropicales     Dr Claudine Duvivier                    9
Paris                                                                   duvivier@pasteur.fr
CHU Sainte Marguerite,          Hématologie et VIH                      Pr Isabelle Poizot Martin              158
Marseille                                                               isabelle.poizot-martin@mail.ap-
                                                                        hm.fr
CHU Purpan,                     Maladies Infectieuses et Tropicales,    Dr Karl Barange                        72
Toulouse                        Hépatogatroentérologie                  barange.k@chu-toulouse.fr
Hôpital Joseph Ducuing,         Médecine                                Dr Alain Bicart See                    32
Toulouse                                                                abicart@hjd.asso.fr
CHU Archet,                     Médecine Interne                        Dr Jacques Durant,                     93
Nice                                                                    durant.j@chu-nice.fr
                                                                        Pr Eric Rosenthal
                                                                        rosenthal.e@chu-nice.fr,
CHU Pellegrin,                  Service des Maladies Infectieuses et    Pr Didier Neau                         128
Bordeaux                        Tropicales                              didier.neau@chu-bordeaux.fr
CHU Saint André,                Médecine Interne et Maladies            Pr Philippe Morlat                     75
Bordeaux                        Infectieuses                            philippe.morlat@chu-bordeaux.fr
CHU Haut Lévèque,               Maladies Infectieuses et Tropicales     Pr Jean-Luc Pellegrin                   5
Bordeaux                                                                 jean-luc.pellegrin@chu-
                                                                        bordeaux.fr
• Total number of inclusions :                          1175 patients
• Followed–up (to date) :                               1145 patients
• Dead :                                                  66 patients
• Visits are made exclusively at hospitals

                                                                                                          Page 2 of 22
3a .1   Are inpatients (ie admitted to a hospital) recruited? No
        Are outpatients recruited?                            Yes
        Any exclusion criteria ? No       If yes, please specify

3b. Cohort enrollment dates

            September 2005 through December 2008




4. Data Collection

4a. Types of data collected – see appendix
Please provide the most updated CRF used for the cohort

                                                                         Check one

Data category        Examples                                 Yes               No
Socio Economic       Employment status                            X
                     educational status                           X
                     family size                                  X
Health services      Type of insurance                                               X
utilization &        Appointments kept/missed                     X
Administration       Other, specify                                                  X
                     Hospital admissions
                             Reasons
                             Duration
Adherence            Patient self-report                          X
                     Interview
Causes of death      Use of Code (ICD-9 ICD-10) MEDDRA            X
Biobank              Plasma, DNA or other stored material for     X
                     planned or unplanned analyses
Any other

4b. Data collection interval

Follow up interval at clinic level and at cohort level (months, IQR):
Yearly as a standard follow-up, except for cirrhotic patients who are followed up every 6 months.
Patients beginning an anti-HCV treatment have 5 extra visits throughout their treatment.

Interval of CD4 and HIV-RNA determination (months, IQR):
12 months (± 6 months)




                                                                                                    Page 3 of 22
 4c. Data collection methodology

Methodology                                                       Yes       No
1. Prospective data collected through interviews with the                        X
patient
2. Prospective data collected through structured                        X
questionnaires
3. Prospective data collected through medical records                   X
4. Retrospective data collected through medical records                 X
5. Any other. Please Specify                                                     X



 4d. Data Quality and ethical clearance (for cohorts participating in D:A:D collaboration, only
 necessary to answer last question)
                                                      Check one
                Examples                             Yes     No      If yes, please provide
                                                                     details*
 Data Quality On site source documentation
 monitoring
                Database quality assurance (data
                entry, consistency checks, query
                listing to sites)
                Documentation available for the
                above (if so, since which calendar
                year)(to be audited by CC)
 Data           Experience with merger of own
 extraction     database with other cohorts for
                scientific collaborations
                Past experience with successfully
                download of data using a format
                comparable with HICDEP format
 Ethical        On site documentation available to
 clearance      collect data in section 4a


 5. Population Characteristics

 5a. Inclusion Criteria
Adult, VIH+, HCV RNA+ or sustained responder after anti-HCV treatment

 5b. Exclusion Criteria
none

 5c. Key information on cohort (only HIV-infected persons)
Total number of adult HIV+ patients recruited (age>= 15 years at the first visit): 1175
Total number of pediatric HIV+ patients recruited: ---
Total number of prospectively collected person-years: 2761
Number of patients followed-up at least once since 2003 : 1175
                                                                                          Page 4 of 22
Number of deaths: 66
Number of persons with > 1 new AIDS diagnosis during prospective follow-up: 10
Number of persons with first AIDS diagnosis during prospective follow-up : 10
Number of CD4 determinations during prospective follow-up: 4549
Number of HIV-RNA determinations during prospective follow-up: 4540
Number of resistance test results available: ---
Number of persons with HbsAg: 22
Number of persons with anti-HCV: 1175
Number of persons with signed informed consent: 1175


5c. 1. Information on any HIV-negative being followed in conjunction with the cohort

Total number of adult HIV- persons recruited:
Total number of pediatric HIV- persons recruited:
Total number of prospectively collected person-years:
Number of persons followed-up at least once in year 2003/4:


5d. Main characteristics of cohort population (information pertains to the entire cohort population –
only HIV+ patients)

i. Females:    29.8      %

ii. Children: ---         %

iii. Median age at enrolment/first visit (IQR):     46 (42 – 48)             yrs

iv. Risk category for HIV acquisition (HICDEP format used):

 Code     Mode of infection (MODE)                                 Percentage
 1        homo/bisexual                                               11.0
 2        injecting drug user                                         61.6
 3        (1 + 2)                                                     1.7
 4        haemophiliac                                                3.2
 5        transfusion, non-haemophilia related                        4.0
 6        heterosexual contact                                        14.6
 7        (6 + 2)                                                      ---
 8        perinatal                                                   0.1
 90       other, (specify)                                            0.1
 99       unknown                                                     3.7

v. Percent of patients on ART treatment in 2003 :             %

vi. Race/Ethnicity (HICDEP format used): UNKNOWN

 Code     Race of patient (RACE)                                   Percentage
 10       White                                                        ---
 20       Black                                                        ---
                                                                                         Page 5 of 22
 Code      Race of patient (RACE)                                  Percentage
 21        Black African                                                 ---
 22        Black Caribbean                                               ---
 30        Hispanic                                                      ---
 40        Asian                                                         ---
 50        American                                                      ---
 60        Indigenous                                                    ---
 1020      1+2                                                           ---
 1040      1+4                                                           ---
 2030      2+3                                                           ---
 3040      3+4                                                           ---
 98        Prohibited                                                   100
 99        Unknown                                                       ---

 vii. Country of origin (HICDEP format used)
 Country of origin is not recorded in the FHDH : we used “stays outside France for more than six
 months since 1978” as a surrogate variable.

 Code      Region codes for origin (ORIGIN)                        Percentage
 12        Stays in Sub-Saharan Africa                                  ---
           Stays in Haïti                                               ---
           Stays in others countries                                    ---
           No stays outside France                                      ---


 viii. Proportion of patients with known date of seroconversion (within a window of 2 years): %

 5e. Characteristics of pediatric population – if applicable




 6. Publication information

 6a. Most appropriate publication as a reference for the cohort (including a general description of the
 cohort) or reference of a report

 The French national prospective cohort of patients co-infected with hiv and hcv (ANRS CO13 HEPAVIH): early
 findings, 2006-2010.
 Loko MA et al. for the ANRS CO13 HEPAVIH Study Group.
 BioMedCentral Infectious Diseases 2010;10(1):303

 6b. Source for obtaining the complete publication list (website/ordered by mail)
http://www.isped.u-bordeaux2.fr/FR_HTM_PubliRechercher.aspx?req=HEPAVIH




                                                                                                  Page 6 of 22
 7. Estimated annual operating expenses for cohort (in Euros)______________
 This information will be kept confidential (i.e. only seen by Genevieve and Jens) and will be used for budgetary purposes only.

 7.1. Please divide this amount into the following categories (total should equal 100%):

 1. Amount used for central datamanagement/QA of database: 30 %
 2. Amount used to support functions at participating sites: 30 %
 3. Amount used for site visits to perform on-site quality assurance: 20 %
 4. Amount used on research projects: 20 %


 8. Declaration of interest for participation in RFA-AI-05-014 (IEDEA)


 I (name): François Dabis, as representative of the ANRS CO13 HEPAVIH cohort, declare my interest to
 participate in RFA-AI-05-014 (IEDEA)

 I would like to express my interest in the following:


 Scientific areas of interest:

Subjects concerning HCV co-infection :

- Effect of NRTI + pegylated interferon in hepatitis C co-infected patients
- Sustained virologial response in hepatitis C co-infected patients
- Hepatocellular carcinoma in HIV patients



 Proposals for scientific ideas to be described in application:




 Thank you!




                                                                                                                         Page 7 of 22
Appendix 1 – identification of variables contained in cohort database (the HICDEP
format is used to create this listing – see www.cphiv.dk/HICDEP
About this document
On the following pages all the data items in the HICDEP are listed. You should use this document to
indicate which of these items you collect in your cohort.

For each item you put an X into either the Yes or No column for each row:
 FIELD NAME             Explanation of Variable                           Yes            No
 PATIENT                Code to identify patient (Cohort Patient ID)
 CENTER                 Code for Clinic/Centre/Hospital where patient is
                           seen.
 BIRTH_D                   Birth date

The structure is hierarchical so that you first need to indicate which of the tables or areas of data you
collect, followed by the individual variables and finally the codes or content in these fields.

E.g. antiretroviral treatment:
Table:
Table                     Does the cohorte have data on:                          Yes    No
tblART                    Type of antiretroviral drug, start and stop dates and
                          reason for stopping

Variables:
 FIELD NAME                Explanation of Variable                                Yes    No
 PATIENT                   Code to identify patient (Cohort Patient ID)
 ART_ID                    Code representing the antiretroviral treatment
 ART_SD                    Date of Initiation of treatment
 ART_ED                    Date of stopping treatment

Codes/content for the ART_ID variable.
Code (Extended         Anti-Retroviral Drugs (ART_ID)                             Yes    No
ATC codes)
J05AF06                  Abacavir (1592U89) (ZIAGEN)
J05AF08                  Adefovir (PREVEON)
J05AE05                  Amprenavir (141W94) (AGENERASE)
J05AE-ATV                Atazanavir (ZRIVADA)

If you indicate No for at the table level you do not need to specify anything at the variable or
code/content level. If you specify no at the variable level you do not need to specify anything at the
code/content level.

Any tables, variables or codes/content you have in your database that are not part of the HICDEP
format listed here and you think should be part of the HICDEP should be listed in separate word or
excel document listing: table, variable and code/content and will be incorporated into the HICDEP
format.




                                                                                              Page 8 of 22
About this document ...................................................................................................................8
1 Data tables .........................................................................................................................10
2 Specific variables and content ..........................................................................................10
  2.1      tblBAS - Basic clinical, background and demographic information ........................10
     2.1.1      Variables (fields) ...............................................................................................10
     2.1.2      Data items (content) ..........................................................................................11
  2.2      tblLTFU – Death and drop-out .................................................................................12
     2.2.1      Variables (fields) ...............................................................................................12
     2.2.2      Data items (content) ..........................................................................................12
  2.3      tblOVERLAP - Cross-cohort identification..............................................................13
     2.3.1      Variables (fields) ...............................................................................................13
  2.4      tblVIS - Basic follow-up/visit related data ...............................................................13
     2.4.1      Variables (fields) ...............................................................................................13
  2.5      tblART - Antiretroviral treatment .............................................................................14
     2.5.1      Variables (fields) ...............................................................................................14
     2.5.2      Data items (content) ..........................................................................................14
  2.6      tblMED - Other medication ......................................................................................15
     2.6.1      Variables (fields) ...............................................................................................15
     2.6.2      Data items (content) ..........................................................................................16
  2.7      tblDIS - Opportunistic infections ..............................................................................17
     2.7.1      Variables (fields) ...............................................................................................17
     2.7.2      Data items (content) ..........................................................................................17
  2.8      tblLAB - Laboratory values ......................................................................................18
     2.8.1      Variables (fields) ...............................................................................................18
     2.8.2      Data items (content) ..........................................................................................18
  2.9      tblLAB_CD4 - Laboratory values ............................................................................19
     2.9.1      Variables (fields) ...............................................................................................19
  2.10 tblLAB_RNA - Laboratory values............................................................................19
     2.10.1     Variables (fields) ...............................................................................................19
     2.10.2     Data items (content) ..........................................................................................19
  2.11 tblLAB_BP - Laboratory values – Blood pressure ...................................................20
     2.11.1     Variables (fields) ...............................................................................................20
  2.12 tblLAB_VIRO - Laboratory values – viro-/serology................................................20
     2.12.1     Variables (fields) ...............................................................................................20
     2.12.2     Data items (content) ..........................................................................................20
  2.13 tblLAB_RES - Resistance testing .............................................................................21
     2.13.1     Variables (fields) ...............................................................................................21
     2.13.2     Data items (content) ..........................................................................................22
  2.14 tblAE - Adverse Events ............................................................................................22
     2.14.1     Variables (fields) ...............................................................................................22
     2.14.2     Data items (content) ..........................................................................................22




                                                                                                                                  Page 9 of 22
Data tables

Table                 Does the cohort have data on:                                Yes   No
tblAE                 Type and date of adverse events                               X
tblART                Type of antiretroviral drug, start and stop dates and         X
                      reason for stopping
tblBAS                Demographics, basic clinical information, date of AIDS        X
                      diagnosis
tblLTFU               Death and drop-out information                                X
tblDIS                Type and date of CDC-C diseases.                              X
tblLAB                Type, date, value and unit of laboratory tests.               X
tblLAB_BP             Date, diastolic and systolic values and unit of blood         X
                      pressure measurements.
tblLAB_CD4            Date and value of CD4 measurements.                           X
tblLAB_RNA            Date, value, detection limit and type of viral assay.         X
tblLAB_RES            Background information on the resistance test,                     X
                      laboratory, library, kit, software and type of test
tblLAB_RES_LVL_       Nucleoside sequence for the PRO and RT sequences                   X
1
tblLAB_RES_LVL_       Mutations and positions of these.                                  X
2
tblLAB_RES_LVL_       Resistance result in relation to antiretroviral drug.              X
3
tblLAB_VIRO           Test results for viro-/serological tests (hepatitis etc.)     X
tblLTFU               Data in death and drop-out                                    X
tblMED                Type, start and stop dates for other HIV related              X
                      medicines.
tblOVERLAP            Information on the patients participation in other cohorts         X
tblVIS                Visit related information, weight, wasting etc.               X




Specific variables and content

tblBAS - Basic clinical, background and demographic
information

Variables (fields)
 FIELD NAME            Explanation of Variable                                     Yes   No
 PATIENT               Code to identify patient (Cohort Patient ID)                 X
 CENTER                Code for Clinic/Centre/Hospital where patient is seen.       X
 BIRTH_D               Birth date (month and year)                                  X
 FRSVIS_D              First seen at clinic                                         X
 ENROL_D               Date of enrolment into the cohort                            X
 GENDER                Gender/sex                                                   X
 HEIGH                 Height of patient at visit/most current                      X
 MODE                  Mode of infection                                            X
 MODE_OTH              Mode of infection OTHER                                      X
 ORIGIN                Nationality or region of origin of patient (surrogate for    X

                                                                                             Page 10 of 22
               this) origin country of parents
ORI_OTH        Origin of patient OTHER
RACE           Race of patient                                           X
SEROCO_D       Date of seroconversion                                    X
RECART_Y       Has the patient received antiretroviral treatment    X
AIDS_Y         Has patient been given an AIDS diagnosis?            X
AIDS_D         IF YES, date of AIDS diagnosis                       X


Data items (content)

Code          Mode of infection (MODE)                             Yes   No
1             homo/bisexual                                         X
2             injecting drug user                                   X
3             (1 + 2)                                               X
4             haemophiliac                                          X
5             transfusion, non-haemophilia related                  X
6             heterosexual contact                                  X
7             (6 + 2)                                               X
8             Perinatal                                             X
90            other, (specify)                                      X
99            Unknown                                               X

Code           Region codes for origin (ORIGIN)                    Yes   No
10             Africa                                               X
11             Northern Africa                                      X
12             Sub-Saharan Africa                                   X
20             Asia                                                 X
30             Oceania (not Australia)                              X
40             Australia & New Zealand                              X
50             Americas                                             X
51             North America                                        X
52             Central & South America                              X
60             Middle East                                          X
70             Europe                                               X
71             Western Europe                                       X
72             Eastern Europe                                       X
99             Unknown                                              X

Code           Race of patient (RACE)                              Yes   No
10             White                                                     X
20             Black                                                     X
21             Black African                                             X
22             Black Caribbean                                           X
30             Hispanic                                                  X
40             Asian                                                     X
50             American                                                  X
60             Indigenous                                                X

                                                                             Page 11 of 22
Code                     Race of patient (RACE)                                    Yes   No
1020                     1+2                                                             X
1040                     1+4                                                             X
2030                     2+3                                                             X
3040                     3+4                                                             X
98                       Prohibited                                                 X
99                       Unknown                                                         X




tblLTFU – Death and drop-out

Variables (fields)

 FIELD NAME              Explanation of Variable                                   Yes   No
 PATIENT                 Code to identify patient (Cohort Patient ID)
 DROP_Y                  Has the patient DROPPED OUT?                               X
 DROP_D                  IF YES, Date of Last Visit                                 X
 DROP_RS                 IF YES, Reason for DROP                                    X
 DEATH_Y                 Has the patient died?                                      X
 DEATH_D                 Date of Death                                              X
 AUTOP_Y                 Was an Autopsy Performed?                                       X
 DEATH_R1                Primary cause of death                                     X
 DEATH_R2                Secondary cause of death                                   X
 DEATH_R3                Tertiary cause of death                                         X
 DEATH_OT                Reason for death – other - description                          X
 ICD10_1                 Primary cause of death as ICD-10                                X
 ICD10_2                 Secondary cause of death as ICD-10                              X
 ICD10_3                 Tertiary cause of death as ICD-10                               X
* to be added at the end of 2005

Data items (content)

Code                     Cause of Death (DEATH_R1, DEATH_R2,                       Yes   No
                         DEATH_R3)
1                        Myocardial Infarction                                      X
2                        Stroke                                                     X
3                        Other cardiovascular diseases                              X
4                        Symptoms caused by mitochondrial toxicity                  X
4.1                      Lactic acidosis                                            X
5                        Complications due to diabetes mellitus                     X
6                        Pancreatitis                                               X
7                        Complications due to hepatitis                             X
7.1                      Hepatitis related                                          X
7.2                      Liver failure not related to hepatitis or mitochondrial    X
                         toxicity
8                        HIV-related                                                X
                                                                                             Page 12 of 22
8.1                    AIDS defining event                                            X
8.2                    Invasive bacterial infection                                   X
9                      Renal failure                                                  X
10                     Bleeding (haemophilia)                                         X
91                     Suicide                                                        X
92                     Drug Overdose                                                  X
90                     Other                                                          X
99                     Unknown, Fatal case with no information


Code                   Reason for Drop Out (DROP_RS)                                 Yes   No
1                      Patient lost to follow-up / Not Known to be dead               X
2                      Patient has not had visit within required amount of time       X
3                      Patient moved away                                             X
4                      Patient moved and is followed by another centre                X
5                      Patients decision                                              X
6                      Consent withdrawn                                              X
7                      Incarceration/jail                                             X
8                      Institutionalisation (drug treatment, psychological …etc.)     X
9                      Other                                                          X


tblOVERLAP - Cross-cohort identification

Variables (fields)

 FIELD NAME              Explanation of Variable                                     Yes   No
 PATIENT                 Code to identify patient (Cohort Patient ID)
 COHORT                  Code/name of the cohort                                           X
 PAT_OTH                 Unique patient identifier in other cohorts
 COH_OTH                 Name of the cohort

Table OVERLAP holds the identifiers of patients in overlapping (super-) cohorts.

A record should be present for each cohort that the patient is participating in (apart from it’s own
“original”-cohort).

tblVIS - Basic follow-up/visit related data

Variables (fields)

 FIELD NAME              Explanation of Variable                                     Yes   No
 PATIENT                 Code to identify patient (Cohort Patient ID)
 VIS_D                   Date of patient visit                                        X
 WEIGH                   Weight of patient at visit/most current                      X
 GAIN_Y                  Is the patient gaining fat in the abdomen, neck, breast      X
                         or other defined locations?
 LOSS_Y                  Is the patient experiencing loss of fat from extremities,    X
                         buttocks or face?

                                                                                               Page 13 of 22
tblART - Antiretroviral treatment

Variables (fields)

FIELD NAME        Explanation of Variable                          Yes   No
PATIENT           Code to identify patient (Cohort Patient ID)
ART_ID            Code representing the antiretroviral treatment    X
ART_SD            Date of Initiation of treatment                   X
ART_ED            Date of stopping treatment since 2005             X
ART_RS            Reason for stopping treatment since 2005          X
ART_DO            Dosage (mg or mL) since (since inception)         X
ART_FR            Frequency                                         X


Data items (content)


Code (Extended   Anti-Retroviral Drugs (ART_ID)                    Yes   No
ATC codes)
J05AF06          Abacavir (1592U89) (ZIAGEN)                        X
J05AF08          Adefovir (PREVEON)                                 X
J05AE05          Amprenavir (141W94) (AGENERASE)                    X
J05AE-ATV        Atazanavir (ZRIVADA)                               X
J05AF01          Zidovudine (AZT, RETROVIR)                         X
J05AF30-COM      Zidovudine/Lamivudine - COMBIVIR (AZT/3TC,         X
                 RETROVIR/EPIVIR)
J05AF04          Stavudine (d4T) (ZERIT)                            X
J05AF03          Zalcitabine (ddC) (HIVID)                          X
J05AF02          Didanosine (ddI) (VIDEX)                           X
J05AG02          Delavirdine (U-90152) (RESCRIPTOR)                 X
J05AG03          Efavirenz (DMP-266) (STOCRIN, SUSTIVA)             X
J05AF-EMT        Emtricitabine (trial drug)                         X
ENF              Enfurvirtide (FUZEON, T-20/Ro 29-9800)             X
J05AF-FOZ        Fozivudine tidoxi                                       X
J05AE-FSP        Fosamprenavir (trial drug)                         X
J05AE-GW4        GW433908/VX-275 (Drug phase III) (PROGENERASE)          X
L01XX05          Hydroxyurea/Hydroxycarbamid (LITALIR)              X
J05AE02          Indinavir (CRIXIVAN)                               X
J05AF-LDN        Lodenosine (trialdrug)                                  X
J05AG-LOV        Loviride                                           X
J05AE06          Lopinavir/Ritonavir (ABT-378/r, Kaletra)           X
J05AE04          Nelfinavir (VIRACEPT)                              X
J05AG01          Nevirapine (VIRAMUN)                               X
J05A-PBT         Participant in Blinded Trial                       X
J05AE03-H        Ritonavir high dose (NORVIR)                       X
J05AE03-L        Ritonavir low dose (NORVIR)                        X

                                                                             Page 14 of 22
Code (Extended   Anti-Retroviral Drugs (ART_ID)                                Yes   No
ATC codes)
J05AE03          Ritonavir (NORVIR)                                             X
J05AE01-SQH      Saquinavir hard gel (INVIRASE)                                      X
J05AE01-SQS      Saquinavir soft gel (FORTOVASE)                                     X
J05AE01          Saquinavir (gel, not specified)                                X
J05AF07          Tenofovir (ViIREAD)                                            X
J05AE-TMC        TMC 114 (Tibotec)                                              X
J05AE-TPR        Tipranavir (trial drug)                                        X
J05AF05          Lamivudine (3TC, EPIVIR)                                       X
J05AF30-TZV      Trizivir                                                       X


Code             Coding for Reason of Stopping Treatment                       Yes   No
                 (ART_RS)
1                Treatment failure (i.e. virological, immunological, and /or    X
                 clinical failure)
2                Abnormal fat redistribution                                    X
3                Concern of cardiovascular disease                              X
3.1              Dyslipidaemia                                                  X
3.2              Cardiovascular disease                                         X
4                Hypersensitivity reaction                                      X
5                Toxicity, predominantly from abdomen/G-I tract                 X
5.1              Toxicity – GI tract                                            X
5.2              Toxicity – Liver                                               X
5.3              Toxicity – Pancreas                                            X
6                Toxicity, predominantly from nervous system                    X
7                Toxicity, predominantly from kidneys                           X
8                Toxicity, predominantly from endocrine system                  X
8.1              Diabetes                                                       X
9                Haematological toxicity (anemia …etc.)                         X
10               Hyperlactataemie/lactic acidosis                               X
88               Death                                                          X
91               Toxicity, not mentioned above ALL TOXICITY                     X
92               Availability of more effective treatment (not specifically     X
                 failure or side effect related)
93               Structured Treatment Interruption (STI)                        X
94               Patient's wish/ decision, not specified above                  X
95               Physician’s decision, not specified above                      X
98               Other causes, not specified above                              X
99               Unknown                                                        X


tblMED - Other medication

Variables (fields)



                                                                                         Page 15 of 22
FIELD NAME         Explanation of Variable                          Yes   No
PATIENT            Code to identify patient (Cohort Patient ID)
MED_ID             Code representing the treatment                   X
MED_SD             Date of Initiation of Treatment                   X
MED_ED             Date of stopping treatment                        X
MED_DO             Dosage (mg or mL)                                      X
MED_FR             Frequency                                              X


Data items (content)


Codes (Extended   Other Hiv-Related Drugs (MED_ID)                  Yes   No
ATC codes)
J01FA09           Clarithromycin (KLACID)                            X
J01GB06           Amikacine (AMIKINE)                                X
J01MA02           Ciprofloxacine (CIPROXINE, CILOXAN)                X
J02AA01           Amphotericin B (FUNGIZON)                          X
J02AB             Imidazoles (DAKTARIN, NIZORAL, PEVARYL …)          X
J02AB02           Ketoconazole                                       X
J02AC01           Fluconazole (DIFLUCAN)                             X
J02AC02           Itraconazole (SPORANOX)                            X
J04AB02           Rifampin (RIMATICIN)                               X
J04AB04           Rifabutin (MYCOBUTIN)                              X
J04AC01           Isoniazid (RIMIFON)                                X
J04AK01           Pyrazinamide (PYRAZINAMID)                         X
J04AK02           Ethambutol (EMB, MYAMBUTOL)                        X
J05AB01           Aciclovir (ZIVORAX)                                X
J05AB06           Ganciclovir (CYMEVENE)                             X
J05AB09           Famciclovir                                        X
J05AB11           Valaciclovir (VALTEX)                              X
J05AB12           Cidofovir (VISTIDE)                                X
J05AD01           Foscarnet (FOSCAVIR)                               X
L01AA01           Cyclophosphamide (ENDOXAN)                         X
L01AD02           CCNU (LOMUSTINE)                                   X
L01AX04           Dacarbazine (DTIC - Dome)                          X
L01BA01           Methotrexate                                       X
L01CA01           Vinblastin (VELBE)                                 X
L01CA02           Oncovin (VINCRISTINE)                              X
L01CB01           Etoposide (VEPESIDE, EXITOP 100)                   X
L01DB01           Doxorubicine, Adriamycine (ADRIBLASTIN, CAELYX,    X
                  DOXIL)
L01DC01           Bleomycine                                         X
L01XB01           Procarbazine (NATULAN)                             X
L03AA02           G-CSF/Filgastrim (NEUPOGEN)                        X
L03AB             Interferons                                        X
L03AC-IL2         Interleukin 2 (PROLEUKIN)                          X


                                                                              Page 16 of 22
tblDIS - Opportunistic infections

Variables (fields)

FIELD NAME      Explanation of Variable                                      Yes   No
PATIENT         Code to identify patient (Cohort Patient ID)
DIS_ID          Code to identify event                                        X
DIS_D           Date of event                                                 X
DIS_WD          Means of diagnosis                                                 X
DIS_OTH         Other location, only to be filled out if code alone is not         X
                sufficient



Data items (content)


Code           Severe Opportunistic Infections (DIS_ID)                      Yes   No
DEM            AIDS dementia complex                                          X
BCNE           Bacterial pneumonia, recurrent (>2 episodes within 1           X
               year)
CANO           Candidiasis, oesophogeal                                       X
CRCO           Cryptococcosis, extrapulm.                                     X
CRSP           Cryptosporidiosis (duration > 1 month)                         X
CMVR           Cytomegalovirus (CMV) chorioretinitis                          X
CMVO           CMV – other location                                           X
HERP           Herpes simplex virus ulcers (duration > 1 month) or            X
               pneumonitis/esophagitis
HIST           Histoplasmosis, extrapulm.                                     X
WAST           HIV Wasting Syndrome                                           X
ISDI           Isosporiasis diarrhoea (duration > 1 month)                    X
LEIS           Leishmaniasis, visceral                                        X
MCDI           Microsporidosis diarrhoes (dur. > 1 month)                     X
MC             Mycobact. avium complex (MAC) or Kanasii, extrapulm.           X
MCP            Mycobact. tuberculosis pulm.                                   X
MCX            Mycobact. tuberculosis extrapulm                               X
MCPO           Mycobact. pulm. , other                                        X
MCXO           Mycobact. extrapulm. , other                                   X
PCP            Pneumocystis carinii pneumonia (PCP)                           X
LEU            Progressive multifocal leucoencephalopathy                     X
SAM            Salmonella bacteriaemia (non-tyhpoid) (recurrent)              X
TOX            Toxoplasmosis, brain                                           X
FBLS           Focal Brain lesion                                             X
Code           Malignancies
KS             Kaposi Sarcoma                                                 X
HG             Hodgkins Lymphoma                                              X
NHG            Non-Hodgkin Lymphoma -not specified                            X
NHGB           Non-Hodgkin Lymphoma – Burkitt (Classical or Atypical)         X
NHGI           Non-Hodgkin Lymphoma – Diffuse large B-cell lymphoma           X
               (Immunoblastic or Centroblastic)

                                                                                       Page 17 of 22
Code           Severe Opportunistic Infections (DIS_ID)         Yes   No
NHGU           Non-Hodgkin Lymphoma - Unknown/other histology    X
NHGP           Non-Hodgkin Lymphoma - Primary Brain Lymphoma     X
CRVC           Cervical Cancer                                   X

Code            Means of diagnosis (DIS_WD)                     Yes   No
1               Definitive diagnosis since 2005                  X
2               Presumptive diagnosis since 2005                 X
3               Diagnosis from autopsy                                X
4               Diagnosis from registry                               X


tblLAB - Laboratory values

Variables (fields)

FIELD NAME      Explanation of Variable                         Yes   No
PATIENT         Code to identify patient (Cohort Patient ID)
LAB_ID          Code representing the measurement                X
LAB_D           Date of measurement/sample                       X
LAB_V           Value of measurement?                            X
LAB_U           What unit of measurement was used ?              X
LAB_FA          Was the blood sample taken while fasting?        X


Data items (content)


Code            Measurement (LAB_ID)                            Yes   No
ALB             Albumine                                         X
ALT             Alanin-Aminotransferase since 2005               X
AMY             Amylase                                          X
APT             Alk. Phosphatate                                 X
AST             Aspartat aminotransferase since 2005             X
BIL             Total Bilirubin                                  X
CHOL            Total Cholesterol since 2005                     X
CRE             Creatinine                                       X
GLUC            Glucose                                          X
HAEM            Haemoglobin                                      X
HDL             Serum HDL since 2005                             X
INR             Quick/INR                                        X
LACT            Lactate                                          X
PP              PP factor (II, VII, X)                                X
THR             Thrombocytes                                     X
TRIG            Serum Triglyceride since 2005                    X
PLT             Platelet count                                   X
WBC             WBC count                                        X
LYMP            Lymphocyte count                                 X
                                                                          Page 18 of 22
tblLAB_CD4 - Laboratory values

Variables (fields)

FIELD NAME      Explanation of Variable                             Yes   No
PATIENT         Code to identify patient (Cohort Patient ID)
CD4_D           Date of measurement                                  X
CD4_V           Value of CD4 measurement                             X


tblLAB_RNA - Laboratory values

Variables (fields)

FIELD NAME      Explanation of Variable                             Yes   No
PATIENT         Code to identify patient (Cohort Patient ID)
RNA_D           Date of Measurement/Sample                           X
RNA_V           HIV-RNA measurement value                            X
RNA_L           Lower Limit of HIV-RNA Assay                         X
RNA_T           Type of VIRAL ASSAY was used for this measurement    X


Data items (content)

Code            Viral assay used (RNA_T)                            Yes   No
10              Roche 1.0                                                 X
15              Roche 1.5 ultra-sensitive                                 X
19              Any Roche (unspecified)                              X
20              NASBA                                                     X
21              NASBA ultra-sensitive                                     X
29              Any NASBA (unspecified)                              X
31              Chiron b-DNA 1.0                                          X
32              Chiron b-DNA 2.0                                          X
33              Chiron b-DNA 3.0                                          X
39              Any Chiron (unspecified)                             X
40              Abbott ultra-sensitive                               X
50              Monitor 1.0                                               X
51              Monitor 1.0 ultra-sensitive                               X
55              Monitor 1.5                                               X
56              Monitor 1.5 ultra-sensitive                               X
65              Cobas 1.5                                                 X
66              Cobas 1.5 ultra-sensitive                                 X
90              Other                                                X
99              Unknown                                              X


                                                                              Page 19 of 22
tblLAB_BP - Laboratory values – Blood pressure

Variables (fields)

FIELD NAME      Explanation of Variable                                  Yes   No
PATIENT         Code to identify patient (Cohort Patient ID)
BP_D            Date of Measurement/Sample                                X
BP_SYS          If the patients Blood Pressure was taken, what was the    X
                Systolic Blood Pressure
BP_DIA          If the patients Blood Pressure was taken, what was the    X
                Diastolic Blood Pressure
BP_U            Unit of measurement was used                              X


tblLAB_VIRO - Laboratory values – viro-/serology

Variables (fields)

FIELD NAME      Explanation of Variable                                  Yes   No
PATIENT         Code to identify patient (Cohort Patient ID)
VS_ID           Viral test                                                X
VS_D            Measurement date                                          X
VS_R            Measurement result                                        X
VS_V            Measurement value                                         X
                (HCV-RNA & HBV-DNA only) (copies/ml)



Data items (content)


Code            Viral test (VS_ID)                                       Yes   No
HCV             Marker for hepatitis C infection - test unknown
HCVA            HCV antibody                                              X
HCVG            HCV antigen                                                    X
HCVR            HCV-rna                                                   X
HBV             Marker for hepatitis B infection (=HBVAC) - test
                unknown
HBVAS           HBV antibody (surface)                                    X
HBVAE           HBV antibody (envelope)                                        X
HBVAC           HBV antibody (core)                                       X
HBVGS           HBV antigen (surface)                                     X
HBVGE           HBV antigen (envelope)                                    X
HBVD            HBV-dna                                                   X
HIV-1           HIV-1 test                                                X
HIV-2           HIV-2 test                                                     X




                                                                                   Page 20 of 22
 tblLAB_RES - Resistance testing

Variables (fields)

tblLAB_RES table - Test background information (main table):
 FIELD NAME           Explanation of Variable                                   Yes   No
 PATIENT              Code to identify patient (Cohort Patient ID)
 SAMP_ID              The assigned sample ID                                          X
 SAMPLE_D             Date of the actual sample taken (NOT the test date)
 SEQ_DT               Date and time when the sequencing was performed
 LAB                  Name of laboratory where the test was performed
 LIBRARY              Library/algorithm used to identify resistance mutations
 REFSEQ               Name/identifier of reference HIV strain used to find
                         mutations
 KIT                     Vendor and version/name of the kit used for the test
 SOFTWARE                Software and version used to determine resistance
 TESTTYPE                Type of test
 RES_CUT                 Cut-off value for phenotype test result
 SUBTYPE                 Subtype of HIV-RNA

tblLAB_RES_LVL_1 Level 1 - Nucleotide sequences (PRO, RT, GP41, GP120) (no entry if the test
was a phenotype test):
 FIELD NAME            Explanation of Variable                           Yes No
 SAMP_ID               The assigned sample ID
 GENE                  Type of nucleotide sequence (part of viral genome
                         sequenced)
 SEQ_STAR                Start position for the sequence
 SEQ_STOP                Stop position for the sequence
 SEQ_NUC                 Nucleotide sequence
 SEQ_AA                  Amino acid sequence

tblLAB_RES_LVL_2 Level 2 – Mutations:
 FIELD NAME        Explanation of Variable                                      Yes   No
 SAMP_ID           The assigned sample ID
 GENE              Type of sequence/gene (PRO, RT, GP41, GP120)
 AA_POS            Position of the mutation in the sequence
 AA_POS_SUB        Subposition used to code insertions
 AA_FOUND_1        Mutation (Amino acid) found in the sequence
 AA_FOUND_2        Mutation (Amino acid) found in the sequence (if more
                         than 1)
 AA_FOUND_3              Mutation (Amino acid) found in the sequence (if more
                         than 2)
 AA_FOUND_4              Mutation (Amino acid) found in the sequence (if more
                         than 3)

AA_FOUND could be extended (AA_FOUND_#) if mixtures with more than 4 amino acids are found.




                                                                                          Page 21 of 22
tblLAB_RES_LVL_3 Level 3 - Resistance test result:
 FIELD NAME       Explanation of Variable                                 Yes   No
 SAMP_ID          The assigned sample ID
 ART_ID           Drug code of antiretroviral
 RES_SCOR         Score of resistance or recommendation given from the
                       test.

Data items (content)


Code                  Type of resistance test (TESTTYPE)                  Yes   No
1                     Genotype
2                     Phenotype
9                     Other


Code                  Sequence type (GENE)                                Yes   No
RT                    Reverse transcriptase sequence
PRO                   Protease sequence
GP41                  GP41 sequence
GP120                 GP120 sequence


tblAE - Adverse Events

Variables (fields)

 FIELD NAME           Explanation of Variable                             Yes   No
 PATIENT              Code to identify patient (Cohort Patient ID)         X
 AE_ID                Full description of the event                        X
 AE_D                 Full description of the event                        X
 AE_NAME              Full name of the event                               X
 AE_DESCRIP           Full description of the event                        X

Data items (content)
Code                 Adverse Event (AE_ID)                                Yes   No
AMI                  Acute myocardial infarction                           X
STR                  Stroke, not specified as haemorrhage or infarction    X
DIA                  Diabetes mellitus                                     X
BYP                  Coronary artery by-pass grafting                      X
END                  Carotic endarterectomy                                X
ANG                  Coronaryangioplasty/stenting                          X
LAC                  Lactate acidosis                                      X
PAN                  Pancreatitis                                          X
REN                  Renal disease - end stage                             X
AVN                  A vascular necrosis in the femural head               X
FRA                  Bone fracture                                         X
HEP                  Severe hepatic encephalopathy (stage III or IV)       X


                                                                                 Page 22 of 22

				
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