ANRS C013 HEPAVIH - Inter-cohort and clinical centers collaboration of subjects co-infected by human immunodeficiency virus and hepatitis C

Head :
Wittkop Linda, INSERM, U1219, Centre de Recherche Inserm Bordeaux Publique Health, équipe Morpheus, CMG-EC
Salmon Dominique, Services des Maladies Infectieuses et Tropicales
Sogni Philippe, Service d'Hépatologie

Last update : 09/13/2018 | Version : 3 | ID : 3626

print
Print
xml
XML

Export to XML

Please choose the format :

pdf
PDF
xml
CSV (Excel)

Export to CSV

What sections do you want to export ?

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
Select all | Invert selection | No selection

Which version do you want to export ?

send
Send
General
Identification
Detailed name Inter-cohort and clinical centers collaboration of subjects co-infected by human immunodeficiency virus and hepatitis C
Sign or acronym ANRS C013 HEPAVIH
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ClinicalTrials : NCT03324633 ; CPP : CG/LG/CC 2005-466
General Aspects
Medical area Immunology
Infectious diseases
Health determinants Lifestyle and behavior
Keywords Adults, disease carriers, cured, treatment, co-infection
Scientific investigator(s) (Contact)
Name of the director Wittkop
Surname Linda
Address VIH, Hépatites Virales et comorbidités : épidémiologie clinique et santé publique / Multimorbidity and Public Health in Patients with HIV or Hepatitis (MORPH3Eus)
CMG-EC de l’INSERM U1219 / ANRS
Université de Bordeaux
ISPED
146, rue Léo Saignat – CS61292
33076 Bordeaux cedex
FRANCE
Phone +33 (0)5 57 57 13 92
Email linda.wittkop@u-bordeaux.fr
Unit INSERM, U1219, Centre de Recherche Inserm Bordeaux Publique Health, équipe Morpheus, CMG-EC
Organization Inserm
Name of the director Salmon
Surname Dominique
Phone +33 (0) 1 42 34 79 56
Email dominique.salmon@aphp.fr
Unit Services des Maladies Infectieuses et Tropicales
Organization Assistance Publique des Hôpitaux de Paris - Hôpitaux Paris Centre, Université Paris Descartes
Name of the director Sogni
Surname Philippe
Address Hôpital Cochin
Email philippe.sogni@aphp.fr
Unit Service d'Hépatologie
Organization Assistance Publique des Hôpitaux de Paris - Hôpitaux Paris Centre, Université Paris Descarte, Inserm
Collaborations
Participation in projects, networks and consortia Yes
Funding
Funding status Mixed
Details ANRS, INSERM, Laboratoires Glaxo-SmithKline, Roche, Schering Plough et Janssen
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 Esterle
Surname Laure
Address VIH, Hépatites Virales et comorbidités : épidémiologie clinique et santé publique / Multimorbidity and Public Health in Patients with HIV or Hepatitis (MORPH3Eus)
CMG-EC de l’INSERM U1219 / ANRS
Université de Bordeaux
ISPED
146, rue Léo Saignat – CS61292
33076 Bordeaux cedex
FRANCE
Phone +(33)5 57 57 92 71
Email laure.esterle@u-bordeaux.fr
Unit INSERM, U1219, Centre de Recherche Inserm Bordeaux Publique Health, équipe Morpheus, CMG-EC
Organization Inserm
Name of the contact ANRS
Address 101 rue de Tolbiac 75013 Paris
Unit Service de recherches fondamentales, cliniques et thérapeutiques sur les Hépatites virales
Organization 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. Dates and inclusions duration: Phase 1: 2005-2008 (3 years) Phase 2: 2011-2014 (3 years)
Database objective
Main objective Short term:
- Describe patient's characteristics
- Analyze factors associated to a treatment of hepatitis C: beginning of the treatment, continuation or stop of the treatment.
- Validate the field performance of not-invasive markers of hepatic fibrosis.

Mid-term:
- Realize an observational study of the evolution of hepatitis during an anti-VHC treatment, in an antiviral situation
- Study the clinical and biological tolerance to the different treatments.
- Study the impact of the observance of the treatment anti HIV and the life quality of patients.

Long term:
Study the natural history of chronic hepatitis, in particular at the stage of cirrhosis.
- Analyze the factors associated to the evolution to fibrosis, to a decompensated hepatic disease or an hepatocellular carcinoma.
- Evaluate the effects of antiretroviral agents on the evolution of not-treated hepatitis
- Study the potential interactions between different virus of hepatitis
Inclusion criteria Adults infected by HIV virus carriers of VHC or cured after anti-VHC treatment, or spontaneously healed without anti-VHC treatment or benefiting from an anti-VHC tritherapies.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered Sick population
Pathology B24 - Unspecified human immunodeficiency virus [HIV] disease
B15-B19 - Viral hepatitis
Gender Male
Woman
Other
Geography area National
Detail of the geography area French multi-centers cohort (28 centers)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 01/2006
Date of last collection (YYYY or MM/YYYY) 09/2022
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 1849 in june 2018
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Details of collected clinical data Clinical examination at inclusion and during the follow-up. Information collected during the clinical examination: weigh, height, waist and hips circumference
Declarative data (detail) Paper self-questionnaire
Face to face interview
Details of collected declarative data Clinical examination at inclusion and during the follow-up. Information collected during the clinical examination: weigh, height, waist and hips circumference
Paraclinical data (detail) Radiology, evaluation of the hepatic fibrosis
Biological data (detail) Blood check
Presence of a biobank Yes
Contents of biobank Whole blood
Serum
Plasma
Details of biobank content Serum bank, plasma bank, DNA bank, total blood, tissues bank in a non-systematic way
Health parameters studied Health care consumption and services
Quality of life/health perception
Care consumption (detail) Medical/paramedical consultation
Medicines consumption
Procedures
Data collection method Self-questionnaire: filled from a paper questionnaire. Interviews: filled from a paper questionnaire .Clinical examination: manual data entry .Biological examination: manual data entry
Classifications used ---
Quality procedure(s) used Data utilization possible for academic teams and for industrials. Temporary access condition : project accepted by the scientific committee
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the referring doctor
Details on monitoring of participants Annual or bi-annual, specific according to the anti-VHC treatment
Links to administrative sources No
Promotion and access
Promotion
Link to the document Liste publications COHORTE ANRS CO13 HEPAVIH 20180830.pdf
Description List of publications in HAL
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=HEPAVIH+OR+ANRS+CO13+OR+%28cohere+AND+%28hiv+OR+AIDS%29%29
Description List of publications in Pubmed
Access
Presence of document that lists variables and coding procedures Yes
Terms of data access (charter for data provision, format of data, availability delay) Data utilization possible for academic teams and for industrials. Temporary access condition : project accepted by the scientific committee
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05