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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

180 µg subcutaneously weekly for 48 weeks

Ribavirin

Intervention Type DRUG

800 mg orally daily for 48 weeks

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

Group Type ACTIVE_COMPARATOR

Peginterferon alfa-2a

Intervention Type DRUG

180 µg subcutaneously weekly for 48 weeks

Ribavirin

Intervention Type DRUG

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

Interventions

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Peginterferon alfa-2a

180 µg subcutaneously weekly for 48 weeks

Intervention Type DRUG

Ribavirin

800 mg orally daily for 48 weeks

Intervention Type DRUG

Ribavirin

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

Intervention Type DRUG

Other Intervention Names

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Pegasys Copegus Copegus

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No