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