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Telaprevir in HIV-HCV Coinfected Patients Failing PegInterferon-Ribavirin
NCT01332955Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2011
- Primary completion
- Sep 2013
- Countries
- 1
- Sponsor
- ANRS
- Modality
- Small Molecules
- Drugs
- telaprevir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, open-label, single-arm trial of telaprevir in hepatitis C (HCV), sponsored by ANRS. Primary endpoint: Sustained Virological Response at 24 weeks after end of therapy. Started Apr 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Telaprevir-pegIFN alfa-2a-ribavirine
Single group receiving lead-in pegIFN+RBV, followed by Telaprevir+pegIFN+RBV, followed by maintenance pegIFN+RBV.
03
Who it enrols
HIV-1 and HCV genotype 1 coinfected patients who previously failed a peginterferon-ribavirin regimen, with stable ARV therapy, CD4 >200, and undetectable HIV-RNA.
04
Endpoints
Primary
Sustained Virological Response at 24 weeks after end of therapy
Secondary
Number of Participants with Adverse Events
Sustained Virological Response at 12 weeks after end of therapy
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