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

NCT00470210 Phase 4 COMPLETED

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.

Details

Lead sponsor	Germans Trias i Pujol Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	10
Start date	2007-05
Completion	2009-06

Conditions

• Hepatitis C
• HIV Infections

Interventions

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

Primary outcomes

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

Countries

Spain