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.

Condition(s) targeted: Hepatitis C, Chronic

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

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Sustained virological response (undetectable HCV RNA)

Anemia, dose reductions and discontinuations due to anemia

Secondary outcome: AEs, laboratory parameters, AIDS-defining events.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

PORTO 4200, Portugal

COIMBRA 3000-075, Portugal

PORTO 4369-004, Portugal

AMADORA 2700-020, Portugal

SANTURCE 00909, Puerto Rico

SAN JUAN 00935, Puerto Rico

PONCE 00716, Puerto Rico

MADRID 08029, Spain

BARCELONA 08901, Spain

BARCELONA 08803, Spain

BARCELONA 08026, Spain

BURGOS 09005, Spain

ALCAZAR DE S JUAN 13600, Spain

MADRID 28905, Spain

LOGROÑO 26001, Spain

MOBILE, Alabama 36693, United States

PHOENIX, Arizona 85048, United States

SAN FRANCISCO, California 94121, United States

SAN DIEGO, California 92103-8465, United States

SAN FRANCISCO, California 94115, United States

SACRAMENTO, California 95814, United States

BEVERLY HILLS, California 90211, United States

LOS ANGELES, California 90028, United States

RIVERSIDE, California 92501, United States

LOS ANGELES, California 90048, United States

WASHINGTON, District of Columbia 20422, United States

ORLANDO, Florida 32803, United States

MIAMI, Florida 33125, United States

JACKSONVILLE, Florida 32209, United States

SARASOTA, Florida 34243, United States

DAYTONA BEACH, Florida 32117, United States

MIAMI, Florida 33136, United States

VERO BEACH, Florida 32960, United States

ATLANTA, Georgia 30308, United States

AUSTELL, Georgia 30106, United States

RIVERDALE, Georgia 30274, United States

CHICAGO, Illinois 60657, United States

BALTIMORE, Maryland 21205, United States

BALTIMORE, Maryland 21201, United States

BOSTON, Massachusetts 02118, United States

WORCESTER, Massachusetts 01655, United States

BOSTON, Massachusetts 02114, United States

SPRINGFIELD, Massachusetts 01107, United States

FRAMINGHAM, Massachusetts 01701, United States

SPRINGFIELD, Massachusetts 01107-1635, United States

KANSAS CITY, Missouri 64131, United States

ROSELAND, New Jersey 07068, United States

MANHASSET, New York 11030, United States

NEW YORK, New York 10035, United States

BRONX, New York 10468, United States

NEW YORK, New York 10029, United States

NEW YORK, New York 10021, United States

CHAPEL HILL, North Carolina 27599-7080, United States

AKRON, Ohio 44304, United States

OKLAHOMA CITY, Oklahoma 73104, United States

ALLENTOWN, Pennsylvania 18102-7017, United States

PHILADELPHIA, Pennsylvania 19104, United States

AUSTIN, Texas 78705, United States

HOUSTON, Texas 77030, United States

DALLAS, Texas 75390, United States

SALT LAKE CITY, Utah 84132, United States

RICHMOND, Virginia 23298, United States

ANNANDALE, Virginia 22003, United States

SEATTLE, Washington 98104, United States

SEATTLE, Washington 98133, United States

Starting date: June 2006
Ending date: March 2009
Last updated: June 17, 2008