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
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring coinfection, protease inhibitor, HIV
Eligibility Criteria
Inclusion Criteria:
- >=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 Criteria:
- 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 Exclusion Criteria:
Hematologic, biochemical, and serologic criteria (growth factors may not be used to achieve trial entry requirements):
- Hemoglobin <11 g/dL for females and <12 g/dL for males
- Neutrophils <1500/mm^3 (blacks/African-Americans: <1200/mm^3)
- Platelets <100,000/mm^3
- Direct bilirubin >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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
PegIFN-2b + RBV
PegIFN-2b + RBV + Boceprevir
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.