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

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Locations

United States, Alabama

Mobile, Alabama, United States, 36693
United States, Arizona

Phoenix, Arizona, United States, 85048
United States, California

San Francisco, California, United States, 94121

San Diego, California, United States, 92103-8465

Los Angeles, California, United States, 90028

Sacramento, California, United States, 95814

Beverly Hills, California, United States, 90211

San Francisco, California, United States, 94115

San Clemente, California, United States, 92673

Los Angeles, California, United States, 90048
United States, District of Columbia

Washington, District of Columbia, United States, 20422
United States, Florida

Orlando, Florida, United States, 32803

Daytona Beach, Florida, United States, 32117

Jacksonville, Florida, United States, 32209

Sarasota, Florida, United States, 34243

Miami, Florida, United States, 33125

Miami, Florida, United States, 33136

Vero Beach, Florida, United States, 32960
United States, Georgia

Atlanta, Georgia, United States, 30308

Austell, Georgia, United States, 30106

Riverdale, Georgia, United States, 30274
United States, Illinois

Chicago, Illinois, United States, 60657
United States, Maryland

Baltimore, Maryland, United States, 21205

Baltimore, Maryland, United States, 21201
United States, Massachusetts

Boston, Massachusetts, United States, 02118

Worcester, Massachusetts, United States, 01655

Boston, Massachusetts, United States, 02114

Springfield, Massachusetts, United States, 01107

Framingham, Massachusetts, United States, 01701

Springfield, Massachusetts, United States, 01107-1635
United States, Missouri

Kansas City, Missouri, United States, 64131
United States, New Jersey

Roseland, New Jersey, United States, 07068
United States, New York

Manhasset, New York, United States, 11030

New York, New York, United States, 10035

Bronx, New York, United States, 10468

New York, New York, United States, 10029

New York, New York, United States, 10021
United States, North Carolina

Chapel Hill, North Carolina, United States, 27599-7080
United States, Ohio

Akron, Ohio, United States, 44304
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania

Allentown, Pennsylvania, United States, 18102-7017

Philadelphia, Pennsylvania, United States, 19104
United States, Texas

Houston, Texas, United States, 77030

Austin, Texas, United States, 78705

Houston, Texas, United States, 77030

Dallas, Texas, United States, 75390
United States, Utah

Salt Lake City, Utah, United States, 84132
United States, Virginia

Richmond, Virginia, United States, 23298

Annandale, Virginia, United States, 22003
United States, Washington

Seattle, Washington, United States, 98104

Seattle, Washington, United States, 98133
Portugal

Porto, Portugal, 4200

Coimbra, Portugal, 3000-075

Porto, Portugal, 4369-004

Amadora, Portugal, 2700-020
Puerto Rico

Santurce, Puerto Rico, 00909

San Juan, Puerto Rico, 00935

Ponce, Puerto Rico, 00716
Spain

Logroño, Spain, 26001

Barcelona, Spain, 08901

Barcelona, Spain, 08803

Barcelona, Spain, 08026

Burgos, Spain, 09005

Alcazar de S Juan, Spain, 13600

Madrid, Spain, 28905

Madrid, Spain, 08029

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 25, 2009