ANRS CO13 – HEPAVIH
Inter Cohorts and Clinical Centres Collaborations of Subjects Co-infected With Hepatitis C and Human Immunodeficiency Virus
Topic
HIV/HCV co-infection
Sponsor
Inserm-ANRS
Coordinating investigator
Dominique Salmon-Céron MD, PhD-AP-HP / Linda Wittkop MD, PhD – Bordeaux / Philippe Sogni MD, PhD-AP-HP
Short description
The cohort has the purpose to become a facility for specific research regarding the physiopathological and therapeutic aspects of the HCV/HIV co-infection at the disposal of the entire scientific community.
Study design
Multicenter, national, observational cohort
Primary objective
The co-primary objectives are :
- To better define the natural history of HIV/HCV co-infection (morbidity and mortality) and its determinants
- To identify clinical and socio-behavioral factors associated with morbidity events and mortality specific to each virus
- To study response and tolerance of new anti-HCV drugs and their long-term benefits
Primary endpoint
Endpoints include :
- Clinical : response to HCV treatment, adverse events related to HCV treatment, decompensated cirrhosis, hepatocarcinoma, liver transplantation, AIDS, cancer, cardiovascular events, antiviral vaccination, death
- Histological : hepatic fibrosis
- Virological : HCV viral load, HIV viral load, resistance mutations
- Socio-behavioral : quality of life, perceived health, adherence to HCV treatment
Study population
HIV/HCV co-infected adult patients
Intervention
Prospective data collection and data collection, standard clinical follow-up as part of care
Number of subjects
1855 participants
Participating country(ies) and sites
France (29 centres)
Study duration
17 years
Funding
Inserm – ANRS | MIE
UMS MART activities
Coordination, Methodology, Monitoring, Data Management and Statistical Analysis