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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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00353418
First received: July 17, 2006
Last updated: July 30, 2010
Last verified: July 2010
Results First Received: May 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Peginterferon alfa-2a
Drug: Ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg No text entered.
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg No text entered.

Participant Flow:   Overall Study
    PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg     PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg  
STARTED     138     277  
COMPLETED     55     119  
NOT COMPLETED     83     158  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sustained Virological Response (SVR)   [ Time Frame: Week 72 ]

2.  Primary:   Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia   [ Time Frame: Up to Week 72 ]

3.  Secondary:   Virological Response at End of Treatment Period   [ Time Frame: Week 48 ]

4.  Secondary:   Virological Response at Weeks 4, 12 and 24   [ Time Frame: Weeks 4, 12 and 24 ]

5.  Secondary:   Relapse of Virological Response   [ Time Frame: Weeks 48 and 72 ]

6.  Secondary:   Rapid Virological Response (RVR) by Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information