Open, Multicentre,Randomized Phase IV Trial to Evaluate Efficacy/Safety to Extend Treatment Duration With Peginterferon Alfa-2a+High Dose of Ribavirin Supporting Epo β in Treatment of CHC in HIV-HCV Patients Who Not Clear Virus at Week 4 (PERICO)

NCT00526448 Phase 4 UNKNOWN

To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according to body weight). To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR = RNA - HCV undetectable at 4 week).

Details

Lead sponsor	Hospital Carlos III, Madrid
Phase	Phase 4
Status	UNKNOWN
Enrolment	384
Start date	2007-06
Completion	2010-02

Conditions

• Chronic Hepatitis C

Interventions

• ribavirin
• ribavirin
• Peginterferon alfa-2a
• epoetin beta

Primary outcomes

• % patients with RNA-HCV < 50 UI/ml — 24 weeks after the end of treatment

Countries

Spain