Boceprevir in HIV-HCV Coinfected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected
patients are non responders after 48 weeks of the current standard-of-care with
Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of
Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy
in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV
co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks
of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to
improve the response rate of the re-treatment of hepatitis C in these patients.
The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in
combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and
chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects
will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined
as undetectable HCV-RNA at Week 24 after the end of therapy.
Phase:
Phase 2
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators:
Merck Sharp & Dohme Corp. Rennes University Hospital