A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)

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/uL 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)