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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00353418 |
This 2 arm study will compare the efficacy and safety of treatment with Pegasys (180 micrograms sc weekly) plus Copegus (800mg po daily) and PEGASYS (180 micrograms sc weekly) plus Copegus (1000-1200mg po 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.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: Copegus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multicenter, Double Blinded, Phase IV Study Comparing the Safety and Efficacy of Pegasys 180 µg Plus Copegus 1000 or 1200 mg to the Currently Approved Combination of Pegasys 180 µg Plus Copegus 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection Coi |
Estimated Enrollment: | 400 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | March 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Drug: Copegus
800mg po daily for 48 weeks
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2: Active Comparator |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1000-1200mg po daily for 48 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NV18209 |
Study First Received: | July 17, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00353418 |
Health Authority: | United States: Food and Drug Administration |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Acquired Immunodeficiency Syndrome Ribavirin Hepatitis, Viral, Human Immunologic Deficiency Syndromes |
Hepatitis Virus Diseases Digestive System Diseases HIV Infections Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |