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. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00353418

Purpose

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

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferons

U.S. FDA Resources

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

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
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353418

Show 66 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 14, 2009