ITMO public health
Last update : 07/01/2013 | Version : 1 | ID : 60076
| General | |
| Identification | |
| Detailed name | Primary infection cohort |
| Sign or acronym | ANRS CO6 PRIMO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n° 997056 du 15/09/1997 ; CPP n°1157, avis favorable le 02/07/1996 ; DGS : n° 960695 le 06/03/1997 |
| General Aspects | |
| Medical area |
Biology Infectious diseases |
| Health determinants |
Geography Social and psychosocial factors |
| Keywords | Heath events, serious pathologies, lipodystrophies, death |
| 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 | INSERM - Institut National de Santé et Recherche |
| Name of the director | Essat |
| Surname | Asma |
| asma.essat@inserm.fr | |
| Organization | INSERM |
| 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 MÉDECINE INTERNE - HÔPITAL BICÊTRE |
| Organization | APHP |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| 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 |
| Sponsor(s) or organisation(s) responsible | INSERM |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Additional information regarding sample selection. |
Type of enrollment: prospective End of enrollment : 31 December 2015 |
| Database objective | |
| Main objective |
Follow up of patients infected by HIV-1 for less than three months. 1. Improve the pathophysiological l knowledge of primary HIV infection - Study of the immune mechanisms involved early after infection - Kinetics of viral replication and establishment of cellular reservoirs at an early stage - Relationships between virological markers and immune response kinetics - Impact of resistance mutations, subtype and tropism on the disease progression and the response to treatment - Study of sub-groups of specific patients followed since primary infection, spontaneous or post treatment controllers, subjects with particular HLA 2. Assessing the impact of early, transient or prolonged treatment versus deferred treatment on the long-term prognosis of patients followed since primary infection, in terms of activation / inflammation and decrease in viral reservoirs 3. Contribute to knowledge in the epidemiology of HIV infection: - Modes of transmission - Sexual behavior before and after HIV diagnosis - Calendar trend of transmitted viral strains diversity (ARV resistance and subtypes) - Calendar trend of marker levels measured at primary infection 4. Contribute to national recommendations for therapeutic care, evaluate their implementation 5. Use observational data from the cohort for the development of therapeutic clinical trials in primary infection |
| Inclusion criteria |
1) symptomatic or asymptomatic HIV-1 primary infection. 2) Infection date based on one of the following criteria: incomplete Western Blot; or positive p24 antigenemia/detectable plasma HIV RNA along with a negative or weakly positive ELISA or a negative or undetermined Western Blot, or a negative ELISA within the three previous months. 3) Enrollment within a maximum of 3 months after the estimated infection date. 4) Naive of antiretroviral treatment except for transient treatment taken in the context of PMTCT, PrEP or PEP. |
| 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 | open, prospective, multicenter (94 centers) cohort |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 11/1996 |
| Date of last collection (YYYY or MM/YYYY) | 2020 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1625 in January 2013 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Biological data (detail) | Blood samples |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma Fluids (saliva, urine, amniotic fluid, …) |
| Details of biobank content | Plasma, Lymph, cells, and total 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 questionnaires: data entered from a questionnaire filled out by the patient by hand Clinical examination: written crf Biological exams: written crf |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Visits, clinical CRF and blood samples at baseline, M1, M3, M6 and then every 6 months. Possible enrollment in one of these additional modules: - Immunology Module: Additional samples for immunological investigations. - Clinical trial module: possible enrollment in a clinical trial. - Partner module: collection of the partner’s blood sample at the time of patient enrollment in the cohort in order to perform specific analysis and record information on their health status. - Spontaneous and post-treatment control modules: additional blood samples for immunological and virological investigations during the control period |
| Links to administrative sources |
Yes |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | data available to academic teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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