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Trial information
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.
Status: No longer recruiting
Protocol number: NV18209
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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. Target sample size is
400.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Sustained virological response (undetectable HCV RNA) Time frame: Week 72
2. Anemia, dose reductions and discontinuations due to anemia Time frame: Throughout study
Key secondary outcomes: 1. AEs, laboratory parameters, AIDS-defining events. Time frame: Throughout study
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: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2006
Trial registration date: 07/19/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:Portugal Spain - Alcazar De S Juan
- Barcelona
- Burgos
- Logroño
- Madrid
United States - Mobile, AL
- Phoenix, AZ
- Beverly Hills, CA
- Los Angeles, CA
- Sacramento, CA
- San Clemente, CA
- San Diego , CA
- San Francisco, CA
- Washington, DC
- Daytona Beach, FL
- Jacksonville, FL
- Miami, FL
- Orlando, FL
- Sarasota , FL
- Vero Beach, FL
- Chicago, IL
- Baltimore, MD
- Boston, MA
- Framingham, MA
- Springfield, MA
- Worcester, MA
- Kansas City, MO
- Roseland, NJ
- Bronx, NY
- Manhasset, NY
- New York, NY
- Chapel Hill, NC
- Akron, OH
- Oklahoma City, OK
- Allentown, PA
- Philadelphia, PA
- Ponce, PR
- San Juan, PR
- Santurce, PR
- Austin, TX
- Dallas, TX
- Houston, TX
- Salt Lake City, UT
- Annandale, VA
- Richmond, VA
- Seattle, WA
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