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 |
Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05