HIV Infections Clinical Trial
Official title:
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (Protocol No. P05411)
The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034)
800 mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b
(PegIFN-2b) 1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of
ribavirin (RBV) (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in
adult participants coinfected with human immunodeficiency virus (HIV) and previously
untreated chronic hepatitis C virus (HCV) genotype 1.
Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically
designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit
viral replication in HCV-infected host cells. The mechanism of inhibition represents a new
mechanism of action compared to both interferon alfa and ribavirin. Based on previous
experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected
population, this combination treatment is expected to provide significant benefit to the
HIV/HCV coinfected population. Given the high unmet medical need of these participants and
the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate
the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants
coinfected with HIV/HCV.
This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in
combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously
untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical
Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one
experimental arm (Arm 2). Participants in the control arm (Arm 1) may receive
boceprevir/PegIFN-2b/RBV via a crossover arm.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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