drugset / Trial / NCT00353418

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

NCT00353418

Phase 4 Completed 415 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-06
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ribavirin Small molecule 800 mg Oral
Comparator Ribavirin Small molecule 1000 mg Oral
Comparator Ribavirin Small molecule 1200 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous