Phase 2
N=99
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)
HIV Infections · Hepatitis C · HCV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00959699 ↗Enrolled (actual)
99
Serious AEs
17.7%
Results posted
Aug 2013
Primary outcome: Primary: Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication — 29.4; 62.5 percentage of participants — p=0.0008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PegIFN-2b (Drug); RBV (Drug); Placebo to Boceprevir (Drug); Boceprevir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication |
29.4; 62.5 | 0.0008 sig |
| SECONDARY Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control) |
30.3; 64.5 | 0.0007 sig |
| SECONDARY Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24 |
0; 0; 100; 100; 100; 92.6 | — |
| SECONDARY Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12) |
26.5; 62.5 | — |
| SECONDARY Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4) |
15; 28; 16; 32; 3; 3 | — |
| SECONDARY Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound |
0; 6.3; 17.6; 9.4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- >=18 and =40 and =200 cells/µL and HIV-1 RNA viral load 1.5 x ULN (upper limit of normal) of the laboratory reference range. Total bilirubin >1.6 mg/dL unless history of Gilbert's disease or antiretroviral regimen contains atazanavir. If Gilbert's disease is the proposed etiology, this must be documented in the participant's chart
- Alpha fetoprotein (AFP):
- AFP >100 ng/mL OR
- AFP 50 to 100 ng/mL (requires a liver ultrasound and participants with findings suspicious for hepatocellular carcinoma are excluded)
Data sourced from ClinicalTrials.gov (NCT00959699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.