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

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ClinicalTrials.gov Identifier: NCT00085917
Recruitment Status : Completed
First Posted : June 17, 2004
Results First Posted : June 15, 2011
Last Update Posted : June 27, 2011
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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
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 
Adverse Event                4                3 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Number of Participants With Sustained Virologic Response (SVR)   [ Time Frame: 72 weeks ]

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

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