Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients (PIFNPK)

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00085917
First received: June 16, 2004
Last updated: June 21, 2011
Last verified: June 2011
Results First Received: April 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C
HIV Infections
Interventions: Drug: Double dose pegylated interferon with weight based Ribavirin
Drug: standard dose pegylated interferon alfa -2a and 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
Recruitment period was over a period of 3 yrs from 2004 - 2007. Participants were recruited and screened through the OP8 clinic of the NIAID.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

There were no significant events or approaches following participant enrollment prior to group assignments.

However if enrolled participants subsequently developed exclusion criteria such as active alcohol or drug abuse, they were excluded from the study.


Reporting Groups
  Description
Pegasys Single Dose

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

Pegasys Double Dose

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks


Participant Flow:   Overall Study
    Pegasys Single Dose     Pegasys Double Dose  
STARTED     15     14  
COMPLETED     11     11  
NOT COMPLETED     4     3  
Adverse Event                 4                 3  



  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.
No text entered.

Reporting Groups
  Description
Pegasys Single Dose

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

Pegasys Double Dose

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks

Total Total of all reporting groups

Baseline Measures
    Pegasys Single Dose     Pegasys Double Dose     Total  
Number of Participants  
[units: participants]
  15     14     29  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     14     29  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  48  ± 6.402     46  ± 5.93     47  ± 6.109  
Gender  
[units: participants]
     
Female     4     4     8  
Male     11     10     21  
Region of Enrollment  
[units: participants]
     
United States     15     14     29  



  Outcome Measures
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1.  Primary:   Number of Participants With Sustained Virologic Response (SVR)   [ Time Frame: 72 weeks ]
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Measure Type Primary
Measure Title Number of Participants With Sustained Virologic Response (SVR)
Measure Description SVR [ Sustained virological response] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.
Time Frame 72 weeks  
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.
No text entered.

Reporting Groups
  Description
Pegasys Single Dose

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

Pegasys Double Dose

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks


Measured Values
    Pegasys Single Dose     Pegasys Double Dose  
Number of Participants Analyzed  
[units: participants]
  11     11  
Number of Participants With Sustained Virologic Response (SVR)  
[units: participants]
  11     11  

No statistical analysis provided for Number of Participants With Sustained Virologic Response (SVR)



2.  Secondary:   Number of Participants With Normalization of Liver Enzymes   [ Time Frame: week 24, week 48, week 72 ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 48 weeks ]


  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
Small number of enrolled participants


  More Information