ITMO public health
Last update : 01/01/2019 | Version : 3 | ID : 60024
| General | |
| Identification | |
| Detailed name | Cohort of HIV-infected patients who began treatment with protease inhibitor in 1997-1999. Follow-up over 4 years on the long-term effects linked with adherence and tolerance (COPILOT). |
| Sign or acronym | ANRS CO8 APROCO-COPILOTE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Infectious diseases |
| Health determinants |
Genetic |
| Keywords | unexpected events, Observed health events, serious adverse events, cardiovascular risk factors |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leport |
| Surname | Catherine |
| Phone | +33 (0)1 57 27 78 68 |
| catherine.leport@univ-paris-diderot.fr | |
| Unit | LABORATOIRE DE RECHERHE EN PATHOLOGIE INFECTIEUSE |
| Organization | ANRS |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | ANRS, COLLEGE DES UNIVERSITAIRES DE MALADIES INFECTIEUSES ET TROPICALES (CMITT EX APPIT), SIDACTION ENSEMBLE CONTRE LE SIDA ABBOTT, BOEHRINGER-INGELHEIM, BRISTOL-MYERS SQUIBB, GILEAD, GLAXO-SMITHKLINE, PFIZER, ROCHE |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Agence Nationale de Recherches 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective |
| Database objective | |
| Main objective | General objective: To investigate determinants for long-term effects of adherence and tolerance to highly active antiretroviral drugs, in relation to patients infected with HIV-1 who were treated for the first time under a protease inhibitor in 1997-99. Secondary objectives: - to determine the part that host genetic polymorphisms play in the progression of the infection and onset of serious adverse events - to investigate viral load and antiretroviral resistance in plasma cell compartments in relation to antiretroviral concentrations over time. |
| Inclusion criteria | Patients included in the APROCO cohort (adults infected with HIV-1 at first prescription of protease inhibitor in 1997-99), monitored for four years in APROCO after initial enrolment, monitored by voluntary services in order to participate in extended follow-up, having given their written consent. |
| 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 | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 03/2003 |
| Date of last collection (YYYY or MM/YYYY) | 01/2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 717: Copilote 1281: Aproco |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Face to face interview |
| Paraclinical data (detail) | Anthropometric measurements |
| Biological data (detail) | Type of samples taken: Blood samples, samples at fasting and after gluose load |
| Presence of a biobank |
Yes |
| Contents of biobank |
Plasma Cell lines DNA |
| Details of biobank content | Plasma bank, DNA bank, cell bank |
| Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: from a paper questionnaire (Manual input) with double data entry Interview: From paper questionnaire (Manual input) with double data entry Clinical Examinations: Handwritten (Manual input) and double data entry |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 10 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/ANRSCO8 |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=ANRS+CO8+OR+Aproco+OR+%28cohere+AND+%28hiv+OR+AIDS%29%29 |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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