ANRS C05 VIH-2 - Natural History of HIV-2-infected Adult Patients Living In France
Head :
Matheron Sophie, MALADIES INFECTIEUSES ET TROPICALES, HOPITAL BICHAT-CLAUDE BERNARD
Last update : 12/01/2020 | Version : 3 | ID : 60089
| General | |
| Identification | |
| Detailed name | Natural History of HIV-2-infected Adult Patients Living In France |
| Sign or acronym | ANRS C05 VIH-2 |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL: 04/02/2003 |
| General Aspects | |
| Medical area |
Infectious diseases |
| Study in connection with Covid-19 |
No |
| Pathology (details) | HIV-2 |
| Health determinants |
Addictions Geography Healthcare system and access to health care services Iatrogenic Lifestyle and behavior Social and psychosocial factors |
| Keywords | HIV; HIV-2; natural history; AIDS |
| Scientific investigator(s) (Contact) | |
| Name of the director | Matheron |
| Surname | Sophie |
| Address | SMIT; Hôpital Bichat, 46, rue Henri Huchard, 75 018 Paris |
| Phone | + 33 (0)1 40 25 72 39 |
| sophie.matheron@aphp.fr | |
| Unit | MALADIES INFECTIEUSES ET TROPICALES, HOPITAL BICHAT-CLAUDE BERNARD |
| Organization | APHP |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | cohort network: ACHIEV2E (network of 14 European and 2 West African centers), |
| Others | Immunovir-2 consortium |
| Funding | |
| Funding status |
Public |
| Details | INSERM-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 |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | Lonbogardi |
| Surname | Julie |
| Address |
CMG-EC de l’INSERM U1219 / ANRS Université de Bordeaux - ISPED 146, rue Léo Saignat – CS61292 33076 Bordeaux cedex |
| Phone | +33 (0)5 57 57 13 92 |
| bph.cohorte_co5_vih-2@dif.credim.u-bordeaux.fr | |
| Unit | CMG-EC/INSERM U1219/ANRS |
| Organization | INSERM / ANRS |
| Name of the contact | Wittkop |
| Surname | linda |
| Address |
CMG-EC de l’INSERM U1219 / ANRS Université de Bordeaux - ISPED 146, rue Léo Saignat – CS61292 |
| Phone | +33 (0)5 57 57 13 92 |
| linda.wittkop@u-bordeaux.fr | |
| Unit | CMG-EC/INSERM U1219/ANRS |
| Organization | INSERM / ANRS |
| 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. |
National Multicentric Open Prospective observational cohort,
Inclusion end date: 30 September 2021 |
| Database objective | |
| Main objective |
Main objective
To study HIV-2 infection in adult patients followed in France. Secondary objectives - To describe the epidemiological and clinical characteristics of participants infected with HIV-2, and the immuno-virological characteristics of the infection. - To study the clinical and immunological progression of HIV-2 infection and the prognostic factors for this progression. - To study the response (clinical, immuno-virological) to antiretroviral treatment and to contribute to the identification of antiretroviral strategies and combinations best suited to the particularities of the infection. - To allow an evaluation of the management practices of the participants - To provide a clinical and biological database and samples for basic science studies on HIV-2 infection. |
| Inclusion criteria |
Inclusion Criteria :
- HIV-2 infection only, diagnosed by ELISA, confirmed by Western-Blot, - Follow-up in one of the investigator centers, - Age greater than or equal to 18 years, - Extended follow-up possible, residence in France planned for at least one year, - Participant's consent to participate, - Possible ALD (Long Term Disorder) status for the participant, or state medical aid (SMA), or declaration of obtaining SMA at the time of inclusion. Criteria for non-inclusion : - HIV-1 infection - double HIV-1 + HIV-2 seropositivity. Translated with www.DeepL.com/Translator (free version) |
| 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 |
| Pathology | I - Certain infectious and parasitic diseases |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | French Multicentric cohort (117 centres until 30/10/2019 then 34 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1994 |
| Date of last collection (YYYY or MM/YYYY) | ongoing |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1185 participants, 540 under follow-up |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at baseline and at 6-month follow-up; information collected during clinical examination: weight, blood pressure, CDC stage B or C events, other clinical events, and, for women, pregnancy and menopause. |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | socio-demographic data, data on diagnosis and circumstances of HIV-2 infection, medical history, drug use, pregnancy(ies), antiretroviral treatment, clinical and biological data. |
| Biological data (detail) | Blood sample |
| Administrative data (detail) | nationality |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Blood cells isolated Others |
| Details of biobank content | plasma bank (/6 months), serum bank and cell bank (/12 months) |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Interview: input from a paper questionnaire with double data entry Clinical examinations: handwritten with double data entry Biological analysis: handwritten with double data entry |
| Quality procedure(s) used | Consistency checks after data entry. Remote and on-site monitoring: return to the source folder for data management and verification. Patients are informed about the use of their data. |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by convocation of the participant Monitoring by crossing with a medical-administrative database |
| Details on monitoring of participants | Visit (clinical examination and blood sample); asymptomatic patients: every 6 months. Antiretroviral treated-patients, 1 month after treatment initiation, then every 3 months, then every 3 or 6 months depending on immunovirological status and adherence. Additional visit in case of intermediate event (start or change of antiretroviral treatment, clinical progression, pregnancy) |
| Followed pathology | I - Certain infectious and parasitic diseases |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-ANRS-CO5-HIV-2 |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=Anrs+AND+%28CO5+OR+%28HIV-2+AND+CO+05%29%29 |
| Description | List of publications in Pubmed |
| Access | |
| Dedicated website | http://www.anrs.fr/index.php/anrs/vih_sida/clinique/repertoire_des_etudes_cliniques |
| Terms of data access (charter for data provision, format of data, availability delay) |
Possible use of the data by academic teams
Time access requirements for academic research (collaborations for virological and immunological satellite studies, and therapeutic trials) Possible use of the data by industrialists Conditions of access possible industrial contractual collaborations (ANRS) |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
