ANRS CO14 IL-2 - Cohort of HIV-Infected Patients Treated with Interleukin-2 (IL-2). Study of Tolerance and Long-Term Clinical and Biological Progression of Immunotherapy Treatment.

Head :
Costagliola Dominique, INSERM U720
ABOULKER Jean-Pierre, INSERM SC10 jp.aboulker@vjf.inserm.fr
LEVY Yves, Inserm U955

Last update : 07/31/2015 | Version : 1 | ID : 60058

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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 Treated with Interleukin-2 (IL-2). Study of Tolerance and Long-Term Clinical and Biological Progression of Immunotherapy Treatment.
Sign or acronym ANRS CO14 IL-2
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation Ethical Research Committee: favourable opinion dated 03/03/2006, no. 06-001 and AFSSAPS: declaration no. 060353
General Aspects
Medical area Immunology
Infectious diseases
Keywords Neoplasia, autoimmune disease, systemic, specific, clinical progression, immunovirology, cardiovascular events
Scientific investigator(s) (Contact)
Name of the director Costagliola
Surname Dominique
Address BP 335 75625 Paris cedex 13
Phone +33(0)1 42 16 42 82
Email dcostagliola@ccde.chups.jussieu.fr
Unit INSERM U720
Name of the director ABOULKER
Surname Jean-Pierre
Address 16 av. Paul Vaillant Couturier, 94708 Villejuif Cedex
Phone +33 (0)1 45 59 51 72 ou +33 (0)1 45 59 51 13
Email jean-pierre.aboulker@inserm.fr
Unit INSERM SC10 jp.aboulker@vjf.inserm.fr
Name of the director LEVY
Surname Yves
Address 8 rue du général Sarrail, 94011 Créteil
Phone +33 (0)1 49 81 36 93
Email yves.levy@hmn.ap-hop-paris.fr
Unit Inserm U955
Organization IMRB (Institut Mondor de Recherche
Collaborations
Others Other associated cohorts: French hospital database (FHDH) on HIV infection.
Funding
Funding status Public
Details ANRS
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 An administrative base or a register
Database recruitment is is made on the basis of: Medication(s) taken
Additional information regarding sample selection. Prospective Inclusion cut-off date: 01/01/2010 Other bodies active in creating this cohort: INSERM U270
Database objective
Main objective General objective: to study the long-term clinical tolerance of IL-2 treatment administered to patients infected with HIV. In particular, to monitor the occurrence of non-Hodgkin's lymphoma, neoplasia, systematic or specific autoimmune diseases and cardiovascular events, including venous or arterial thrombosis. Secondary objective: to investigate clinical progression (occurrence of events related to HIV and AIDS classification) and biological progression (CD4 and CD8 immune response and viral load) of HIV infection.
Inclusion criteria HIV-infected individuals over 18 years of age that have received at least one course of IL-2 in the ANRS trial or authorisation for temporary use, who have given signed consent and are affiliated members or beneficiaries of a social security scheme.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Multicentric cohort throughout France (20 centres)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 01/2007
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 613 Number of required subjects : [500-1000]
Data
Database activity Current data collection
Type of data collected Clinical data
Paraclinical data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Details of collected clinical data Clinical examination at baseline and during follow-up. Frequency of examination: 4 years Information collected during clinical examination: IL2 tolerance, clinical and immuno-virological monitoring of HIV infection.
Paraclinical data (detail) Anthropomorphic data (lipodystrophy)
Biological data (detail) Type of samples taken: Blood
Presence of a biobank Yes
Contents of biobank Whole blood
Serum
Plasma
Details of biobank content Biobank: Serum Bank, plasma bank, whole blood
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method Clinical examination: manual input
Quality procedure(s) used Request for consistency after data is processed electronically Missing data is managed by returning to source file or third party
Participant monitoring Yes
Details on monitoring of participants Follow-up duration: 3 years, monitoring until 30th June 2013, modified in accordance with protocol amendment
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Data may be used by academic teams Access in accordance with agreement from sponsor and Scientific Council Data may be used by industrial teams Access in accordance with agreement from sponsor, their Board of Directors and the cohort Scientific Council under contract.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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