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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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 ]

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 ]
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Measure Type Secondary
Measure Title Virological Response at End of Treatment Period
Measure Description Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

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.

Measured Values
    PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg     PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg  
Number of Participants Analyzed  
[units: participants]
  135     275  
Virological Response at End of Treatment Period  
[units: Percentage¬†of¬†participants]
  30     35  

No statistical analysis provided for Virological Response at End of Treatment Period



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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