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. - Tabular View

Tracking Information

First Received Date ^ICMJE

July 17, 2006

Last Updated Date

September 16, 2009

Start Date ^ICMJE

June 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Sustained virological response (undetectable HCV RNA) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Anemia, dose reductions and discontinuations due to anemia [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Sustained virological response (undetectable HCV RNA at week 72). Safety: Anemia, dose reductions and discontinuations due to anemia.

Change History

Complete list of historical versions of study NCT00353418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AEs, laboratory parameters, AIDS-defining events. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

AEs, laboratory tests, AIDS defining events.

Descriptive Information

Brief Title ^ICMJE

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.

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Drug: peginterferon alfa-2a (40KD) [PEGASYS]
Drug: Copegus

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

March 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Portugal, Puerto Rico, Spain

Administrative Information

NCT ID ^ICMJE

NCT00353418

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

NV18209

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP