ITMO public health
Last update : 10/25/2017 | Version : 3 | ID : 8455
| General | |
| Identification | |
| Detailed name | VISCONTI cohort : International-Viro-Immunologic Sustained CONtrol after Treatment Interruption |
| Sign or acronym | ANRS EP 47 VISCONTI |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL approval |
| General Aspects | |
| Medical area |
Immunology Infectious diseases |
| Health determinants |
Iatrogenic Medicine |
| Keywords | primary infection, HIV treatment, functional remission, genetic characteristics, seropositivity, immune system, HIV |
| Scientific investigator(s) (Contact) | |
| Name of the director | Saez-Cirion |
| Surname | Asier |
| Address | 25-28 RUE DU DOCTEUR ROUX 75015 PARIS |
| asier.saez-cirion@pasteur.fr | |
| Organization | ANRS - Institut |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | ANRS |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | ANRS - AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | Hocqueloux |
| Surname | Laurent |
| laurent.hocqueloux@chr-orleans.fr | |
| Organization | CENTRE HOSPITALIER RÉGIONAL D'ORLÉANS |
| 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 |
| Database objective | |
| Main objective | I-VISCONTI is a multicenter, multidisciplinary (clinicians, virologists, immunologists and epidemiologists) pathophysiologic study designed to explore the virological and immunological mechanisms responsible for sustained control of HIV-1 infection after ART interruption in adults or children who started treatment very early in the primary infection or during the chronic phase. I-VISCONTI also aims to identify markers that could be used to identify patients who could reasonably interrupt their antiretroviral treatment. |
| Inclusion criteria |
Patients infected with HIV-1 and not co-infected with HIV-2
- Whatever is the age at the time of HIV-1-infection - Plasma HIV RNA > 2000 copies/mL before initiation of antiretroviral therapy - Treatment started during the primary infection (as defined by symptoms associated with seroconversion, as confirmed by a first negative ELISA and/or an incomplete P24-positive Western blot), at the time of delivery for children or during the chronic phase of infection, and maintained for at least 12 months in both cases. - Control of viral load after antiretroviral treatment interruption: patients must have at least two available viral load assays after stopping antiretroviral therapy. All viral loads must be <400 copies/mL for 12 months or more after stopping antiretroviral therapy, with the possible exception of one blip (one viral load above 400 copies/mL between two viral loads <400 copies/mL at least one month apart from the blip; in this case at least three viral load assays will be required). The last plasma viral load value at the time of inclusion must always be <400 copies/mL |
| Population type | |
| Age |
Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Pathology | Z21 - Asymptomatic human immunodeficiency virus [HIV] infection status |
| Gender |
Male Woman Other |
| Geography area |
International |
| Detail of the geography area | Metropolitan France. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 14 patients (primary infection). |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Biological data (detail) | Blood test. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Plasma Blood cells isolated DNA |
| Details of biobank content | Consult the scientist in charge. |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 7.5 years. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=ANRS+AND+visconti |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | PLOS PATHOGENS publication. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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