A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Peginterferon alfa-2a; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353418

NV18209

Details and patient eligibility

About

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.

Enrollment: 415 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, ≥18 years of age
• CHC genotype 1
• Stable HIV-1 infection

Exclusion criteria

• Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors
• Medical condition associated with liver disease other than CHC infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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415 participants in 2 patient groups

PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg

Experimental group

Treatment:

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon alfa-2a

PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg

Active Comparator group

Treatment:

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon alfa-2a