A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients. The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment. In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%. The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment. Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.
To evaluate efficacy of extend treatment during 24 weeks more in co-infected HIV-HCV patients with genotype 1 and/or 4 who at 44 week of treatment with peginterferón alfa-2a in combination with ribavirin have RNA-HCV undetectable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain
Hospital Insular
Las Palmas, Gran Canaria, Spain
Hospital Clínico Universitario San Cecilio
Granada, Granada, Spain
Hospital de Donostia
San Sebastián, Guipúzcoa, Spain
Complejo Hospitalario Universitario
Santiago, La Coruña, Spain
Fundación Hospital de Alcorcón
Alcorcón, Madrid, Spain
...and 9 more locations
% of patients with RNA-HCV undetectable
Time frame: at 48 week of study (24 weeks after the end of treatment period of trial).
% of percentage of patients with RNA-HCV undetectable
Time frame: 24 weeks of trial period
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