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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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Peginterferon alfa-2a (Drug); Ribavirin (Drug); Ribavirin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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.

Clinical Details

Official title: A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naďve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Sustained Virological Response (SVR)

Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia

Secondary outcome:

Virological Response at End of Treatment Period

Virological Response at Weeks 4, 12 and 24

Relapse of Virological Response

Rapid Virological Response (RVR) by Week 4

Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Clinical Study Report Synopsis

Starting date: June 2006
Last updated: July 30, 2010

Page last updated: August 23, 2015

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