Status:
COMPLETED
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 wee...
Eligibility Criteria
Inclusion
- \>=18 and \<=65 years of age
- Body weight \>=40 and \<=125 kg
- Documented history of HIV infection for greater than 6 months prior to Day 1
- On an optimized anti-retroviral treatment regimen (OTR) with stable HIV disease with CD4 \>=200 cells/µL and HIV-1 RNA viral load \<50 copies/mL
- Documented chronic hepatitis C (CHC) genotype 1 infection (greater than 6 months prior to Day 1)
- Use of acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months or longer after treatment
- Liver biopsy with histology consistent with CHC and no other etiology
Exclusion
- Participants who received prior treatment for hepatitis C other than herbal remedies except those with known hepatotoxicity
- Coinfected with hepatitis B virus (Hepatitis B surface antigen (HBsAg) positive) and/or demonstrating signs and symptoms consistent with concomitant infection
- Evidence of decompensated liver disease
- Participants who have changed their anti-retroviral regimen within the last 3 months prior to Day 1 or had first initiated anti-retroviral therapy within the last 6 months prior to Day 1
- Use of certain HIV medications will not be allowed. Medications will be reviewed by the Investigator
- History of clinically significant opportunistic infections (except oral thrush) within the last year prior to Day 1
- Current evidence of substance abuse within 3 years of the Screening Visit
- History of a clinical diagnosis within the past 6 months of substance abuse prior to Day 1
- Participants receiving opiate agonist substitution therapy but not enrolled in an opiate substitution maintenance program
- History of marijuana use deemed excessive by the Investigator
- Infected with HIV-2
- Use of any HIV protease inhibitor without the coadministration of ritonavir within one month of Day 1 and throughout the period of the trial
- Participants receiving any of the following medication(s) within 2 weeks prior to the Day 1 visit: alfuzosin, antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, and quinidine), ergot derivatives, cisapride, lovastatin, simvastatin, pimozide, triazolam, and orally administered midazolam.
- Key Laboratory
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00959699
Start Date
November 1 2009
End Date
October 1 2012
Last Update
April 7 2017
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