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

History of Changes

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.

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

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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