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