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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
History of Changes
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
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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.
Total Total of all reporting groups

Baseline Measures
    PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg     PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg     Total  
Number of Participants  
[units: participants]
 		  138     277     415  
Age, Customized [1]
[units: Participants]
 		     
< 65 years     134     273     407  
>=65 years     1     2     3  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  45.2  ± 8.39     45.5  ± 8.16     45.4  ± 8.24  
Gender [1]
[units: Participants]
 		     
Female     29     51     80  
Male     106     224     330  
[1] The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.



  Outcome Measures
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1.  Primary:   Sustained Virological Response (SVR)   [ Time Frame: Week 72 ]
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2.  Primary:   Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia   [ Time Frame: Up to Week 72 ]
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3.  Secondary:   Virological Response at End of Treatment Period   [ Time Frame: Week 48 ]
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4.  Secondary:   Virological Response at Weeks 4, 12 and 24   [ Time Frame: Weeks 4, 12 and 24 ]
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5.  Secondary:   Relapse of Virological Response   [ Time Frame: Weeks 48 and 72 ]
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6.  Secondary:   Rapid Virological Response (RVR) by Week 4   [ Time Frame: Week 4 ]
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7.  Secondary:   Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12   [ Time Frame: Week 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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