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

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.
• •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)