ANRS CO8 APROCO-COPILOTE - 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). ARCHIVE

Head :
Leport Catherine, LABORATOIRE DE RECHERHE EN PATHOLOGIE INFECTIEUSE

Last update : 01/01/2019 | Version : 3 | ID : 60024

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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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