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 ]
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Measure Type Primary
Measure Title Sustained Virological Response (SVR)
Measure Description SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
Time Frame Week 72  
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  
Sustained Virological Response (SVR)  
[units: Percentage¬†of¬†participants]
  19     22  


Statistical Analysis 1 for Sustained Virological Response (SVR)
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.6119
Odds Ratio (OR) [4] 1.15
95% Confidence Interval ( 0.68 to 1.93 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

Sample sizes of 133 and 267 patients for RBV 800 mg daily and RBV 1000 or 1200 mg daily, respectively, provided the following probabilities of detecting the specified differences in SVR with a 0.05 level two-sided chi-square test of significance:

RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.40; Probability - 0.49

RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.45; Probability - 0.83

[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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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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