Last update : 02/17/2020 | Version : 1 | ID : 73422
General | |
Identification | |
Detailed name | ANRS CO21 Cohort |
Sign or acronym | CODEX |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP 11-033 |
General Aspects | |
Medical area |
Infectious diseases |
Health determinants |
Genetic Healthcare system and access to health care services Lifestyle and behavior Social and psychosocial factors |
Keywords | HIV Controllers, HIV infection |
Scientific investigator(s) (Contact) | |
Name of the director | Lambotte |
Surname | Olivier |
Address | Hôpital de Bicêtre, Service de Médecine Interne, 78 rue du Général Leclerc, Le Kremlin-Bicêtre 94276 |
Phone | 0145212783 |
olivier.lambotte@aphp.fr | |
Organization | AP-HP |
Collaborations | |
Participation in projects, networks and consortia |
Yes |
Funding | |
Funding status |
Public |
Details | ANRS |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | ANRS |
Organisation status |
Public |
Presence of scientific or steering committees |
Yes |
Additional contact | |
Name of the contact | Boufassa |
Surname | Faroudy |
Address | INSERM CESP U1018, Hôpital de Bicêtre, Service de Médecine Interne, 82 rue du Général Leclerc, Le Kremlin-Bicêtre 94276 |
Phone | 0145212365 |
faroudy.boufassa@inserm.fr | |
Unit | Epidémiologie |
Organization | INSERM |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Cohort study |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is is made on the basis of: |
Another treatment or procedure |
Database recruitment is carried out as part of an interventional study |
No |
Database objective | |
Main objective | In HIV-1 positive patients who have been asymptomatic for at least 5 years after HIV infection in the absence of antiretroviral therapy, whether they meet the definitions of Long time non-Progressors and/or HIV Controllers and in patients on antiretroviral therapy and in "control after discontinuation of antiretroviral therapy", study their clinical and immuno-virological course and define the virus and host parameters associated with non-progression of infection. |
Inclusion criteria |
LTNP subjects: Long Term Non Progressors: HIV-1 positive subjects for at least 8 years with a CD4+ lymphocyte count greater than 600/mm3 and stable or increasing (positive or zero slope) on at least 3 consecutive tests performed in the last 5 years regardless of viral load in the absence of antiretroviral treatment.
HIC (HIV Controllers)" subjects: HIV-1 positive subjects for at least 5 years, asymptomatic, with the last 5 consecutive plasma HIV RNA viral loads < 400 copies/mL whatever the CD4+ level in the absence of antiretroviral treatment. LTNP-HIC" subjects: subjects meeting the double definition of LTNP and HIC, i.e. HIV-1 subjects who have been HIV-positive for at least 8 years and CD4+ lymphocyte count greater than 600/mm3 with a stable or increasing level (positive or zero slope) on at least 3 consecutive examinations carried out over the last 5 years and with the last 5 consecutive plasma HIV-RNA viral loads < 400 copies/mL. Subjects in "post-treatment control" (or post-treatment controllers, PTC): Subjects who had a plasma HIV-RNA viral load > 2000 copies/mL prior to initiation of antiretroviral therapy in either primary or chronic phase and who were maintained on antiretroviral therapy for at least 12 months; in whom, after antiretroviral therapy was discontinued, the viral load remained < 400 copies/mL for more than 12 months with the exception of one blip (plasma viral load above 400 copies/mL) surrounded by two viral loads < 400 copies/mL. The last plasma viral load at the time of inclusion should, in all cases, be < 400 copies/mL. |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
Population covered |
Sick population |
Pathology | B20-B24 - Human immunodeficiency virus [HIV] disease |
Gender |
Male Woman Other |
Geography area |
National |
Detail of the geography area | Fance and DOM-TOM |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2014 |
Size of the database | |
Size of the database (number of individuals) |
< 500 individuals |
Details of the number of individuals | 346 |
Data | |
Database activity |
Current data collection |
Type of data collected |
Clinical data Biological data |
Clinical data (detail) |
Direct physical measures Medical registration |
Presence of a biobank |
Yes |
Contents of biobank |
Whole blood Serum Plasma Blood cells isolated |
Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
Procedures | |
Participant monitoring |
Yes |
Monitoring procedures |
Monitoring by contact with the referring doctor |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Availability of data after validation of a research project by the Scientific Council of the cohort. Data format on tables (SAS, Excel, Stata). |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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