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

Phase 4

Completed

• Conditions: Hepatitis C; HIV Infections
• Interventions: Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week; Drug: Ribavirin (Copegus®) 1600 mg/day; Drug: Epoetin β (450 UI/kg/week)

• Registration Number: NCT00470210
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-04
• Study First Submitted QC: 2007-05-04
• Study First Posted: 2007-05-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Exclusion Criteria

• Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
• Patients with Child-Pugh B or C cirrhosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL	24 weeks after finishing treatment

Secondary Outcome Measures

Name	Time	Method
Changes in serum HCV-RNA titers	between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment
Percentage of patients with serum HCV-RNA loads of < 50 IU/mL	at weeks 4, 8, 12, 24, and 48

Trial Locations

Locations (2)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain