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Sponsored by: |
Hospital Carlos III, Madrid |
Information provided by: | Hospital Carlos III, Madrid |
ClinicalTrials.gov Identifier: | NCT00526448 |
To compare the sustained virological response (SVR = RNA-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 body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according 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).
Condition | Intervention | Phase |
Chronic Hepatitis C |
Drug: ribavirin |
Phase IV |
MedlinePlus related topics: | AIDS Hepatitis Hepatitis C |
ChemIDplus related topics: | Ribavirin Peginterferon Alfa-2a |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 384 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | February 2010 |
Arms | Assigned Interventions |
1: Experimental
Peginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week
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Drug: ribavirin
2000 mg/day
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2: Active Comparator
Peginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day
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Drug: ribavirin
1000-1200 mg/day
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PRESCO study showed that ribavirin dose 1000-1200 mg/day have 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 benefit to extend the treatment duration in patients without rapid virological response at 4 week (RNA-HCV < 50 UI/ml)
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vicente Soriano, Dr | +34914532500 | vsoriano@dragonet.es |
Contact: Pablo Barreiro, Dr | +34914532500 | pbarreiro@v4066.drago.net |
Show 40 Study Locations |
Hospital Carlos III, Madrid |
Study Chair: | Vicente Soriano, Dr | Hospital Carlos III. Madrid. Spain |
Study ID Numbers: | 2006-005940-99 |
First Received: | September 5, 2007 |
Last Updated: | September 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00526448 |
Health Authority: | Spain: Spanish Agency of Medicines |
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