Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 415
Healthy volunteers: no

Brief summary:
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin intervention 3: Ribavirin
Intervention descriptions: intervention 1: 180 µg subcutaneously weekly for 48 weeks intervention 2: 800 mg orally daily for 48 weeks intervention 3: 1000 mg or 1200 mg (based on patient weight of \< 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks

Protocol document: