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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Anemia Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

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 ]

Enrollment:	415
Study Completion Date:	September 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

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	NV18209
Study First Received:	July 17, 2006
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00353418 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Liver Diseases
Slow Virus Diseases
Hepatitis, Chronic
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Ribavirin
Hepatitis, Viral, Human
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

Hepatitis C
Retroviridae Infections
RNA Virus Infections
Immune System Diseases
Growth Substances
Acquired Immunodeficiency Syndrome
Angiogenesis Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 27, 2009