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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2010-08-03

Study results available
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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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Peginterferon alfa-2a

180 µg subcutaneously weekly for 48 weeks

DRUG

Ribavirin

800 mg orally daily for 48 weeks

DRUG

Ribavirin

1000 mg or 1200 mg (based on patient weight of \< 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-04-30
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00353418 on ClinicalTrials.gov