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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
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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
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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)
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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
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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
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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
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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.
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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
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