NCT00526448

Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Hospital Carlos III, Madrid · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The PRESCO study (ribavirin dose 1000-1200 mg/day) emphasized that optimal ribavirin exposure seems to be crucial to maximize sustained virological response and minimize the incidence of relapses after treatment discontinuations. Recent reports showed that it is beneficial to extend the treatment duration in patients without rapid virological response at 4 weeks (RNA-HCV \< 50 UI/ml).

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	ribavirin	2000 mg/day
DRUG	ribavirin	1000-1200 mg/day
DRUG	Peginterferon alfa-2a	Peginterferon alfa-2a 180 mcg/week
DRUG	epoetin beta	epoetin beta 450 UI/week

Timeline

• Start date: 2007-06-01
• Completion: 2010-02-01
• First posted: 2007-09-10
• Last updated: 2009-01-29

Locations

40 sites across 1 country: Spain