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

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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 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
Email 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
Email 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
Email 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

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