ANRS CO9 COPANA - Cohort of HIV-Infected Patients with No Antiretroviral Treatment At Baseline
Head :
Meyer Laurence, U822
Goujard Cécile, Service de médecine interne - Hôpital de Bicêtre
Ghislain Mathilde, Nutrition, Hormones et Santé des FemmesÉquipe: Epidémiologie du VIH et des infections sexuellement transmissibles
Goujard Cécile, Service de médecine interne - Hôpital de Bicêtre
Ghislain Mathilde, Nutrition, Hormones et Santé des FemmesÉquipe: Epidémiologie du VIH et des infections sexuellement transmissibles
Last update : 08/05/2015 | Version : 2 | ID : 7161
| General | |
| Identification | |
| Detailed name | Cohort of HIV-Infected Patients with No Antiretroviral Treatment At Baseline |
| Sign or acronym | ANRS CO9 COPANA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL no. 04-1388 (08/09/2004), CPP no. 2087 (08/07/2003), DGS no. 2003/0455. |
| General Aspects | |
| Medical area |
Biology Infectious diseases |
| Health determinants |
Genetic |
| Keywords | living conditions, mortality, health event, metabolic disorders, fat distribution disorders, treatment response |
| Scientific investigator(s) (Contact) | |
| Name of the director | Meyer |
| Surname | Laurence |
| Address | 94276 LE KREMLIN BICÊTRE |
| Phone | +33 (0)1 45 21 23 34 |
| laurence.meyer@inserm.fr | |
| Unit | U822 |
| Organization | Institut National de Santé et Recherche |
| Name of the director | Goujard |
| Surname | Cécile |
| Address | 94275 LE KREMLIN BICÊTRE |
| Phone | + 33 (0)1 45 21 25 77 |
| cecile.goujard@bct.aphp.fr | |
| Unit | Service de médecine interne - Hôpital de Bicêtre |
| Organization | Assistance Publique - Hôpitaux de |
| Name of the director | Ghislain |
| Surname | Mathilde |
| Address | 94276 LE KREMLIN BICÊTRE |
| Phone | +33 (0)1 45 21 23 38 |
| mathilde.ghislain@inserm.fr | |
| Unit | Nutrition, Hormones et Santé des FemmesÉquipe: Epidémiologie du VIH et des infections sexuellement transmissibles |
| Organization | Institut National de Santé et Recherche |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | ANRS |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Agence Nationale de Recherche sur le Sida et les hépatites virales ANRS |
| Organisation status |
Public |
| Additional contact | |
| 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: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective. Inclusion cut-off datet: 01/01/2008. |
| Database objective | |
| Main objective |
Main objective:
To study the short-, medium- and long-term prognosis for newly diagnosed HIV patients. To investigate HIV-related clinical events, unexpected diseases, neoplastic diseases and long-term immuno-virological progression; to investigate the impact of HIV treatment on morbidity and mortality, factors associated with treatment response, clinical and biological complications, consequences, especially lipodystrophy and metabolic abnormalities, associated factors, including genetic factors; long-term therapeutic adherence, particularly the frequency and impact of treatment interruptions; to investigate the development in living conditions and behaviour of recently diagnosed patients, particularly regarding sexuality, reproduction, and health inequalities. |
| Inclusion criteria |
Patients infected with HIV-1 with recent seropositive diagnosis (less than 1 year) and untreated at enrolment - age 15 or over and agreeing to participate in the cohort.
One third of the patients were included in the TM module (metabolic disorders). This module includes additional biological and imaging examinations. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Multcentric French cohort (37 centres). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2004 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 800 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at baseline and every two years during follow-up. Information collected during clinical examination: clinical examination includes physician screening and monitoring of fat distribution abnormalities. |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Self-administered questionnaire at baseline and during follow-up every year. Information collected by self-administered questionnaire: food consumption, physical activity, smoking, self-evaluation of morphological disorders and living conditions. |
| Paraclinical data (detail) | Imaging. |
| Biological data (detail) | Blood sample. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma Fluids (saliva, urine, amniotic fluid, …) |
| Details of biobank content | Serum bank, plasma bank, lymph bank and whole blood. |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | Self-administered questionnaire: input from a paper questionnaire. Clinical examinations: handwritten. Biological analysis: handwritten. |
| Quality procedure(s) used | Consistency request after electronic data is recorded. Missing data is managed by returning to source record. Physician reminder for follow-up visits. Patients are informed about the use of their data. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Visit every 6 months for 10 years. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/ANRSCO9 |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28Copana+AND+Anrs%29+OR+ANRS+CO9 |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data can be used by academic teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
