Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-06-30

Brief Summary

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This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.

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Detailed Description

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The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d.

The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d.

The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of \< 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.

Conditions

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Hepatitis C HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)

Group Type EXPERIMENTAL

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week

Intervention Type DRUG

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week

Ribavirin (Copegus®) 1600 mg/day

Intervention Type DRUG

Ribavirin (Copegus®) 1600 mg/day

Epoetin β (450 UI/kg/week)

Intervention Type DRUG

Epoetin β (450 UI/kg/week)

Interventions

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Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week

Intervention Type DRUG

Ribavirin (Copegus®) 1600 mg/day

Intervention Type DRUG

Epoetin β (450 UI/kg/week)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-infected patients coinfected with HCV genotypes 1 or 4
* Persistent transaminase elevation
* Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d.