NCT00470210

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

Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C
• HIV Infections

Interventions

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

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-05-07
• Last updated: 2019-12-05

Locations

2 sites across 1 country: Spain