Telaprevir in HIV-HCV Coinfected Patients Who Had Previously Failed a Peginterferon-Ribavirin Regimen
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
This phase II, multicentric, national pilot trial is designed to estimate the sustained
virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a
48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological
response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR to
20%, a rate determining a significant therapeutic benefit in this population of patients. The
primary endpoint will be the SVR defined as undetectable HCV-RNA measured 24 weeks after the
end of therapy (EOT).
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)