HIV Infection Clinical Trial
Official title:
Efficacy of High Doses of Both Pegylated Interferon Alfa-2a and Ribavirin for Retreatment of HIV-coinfected Patients With Liver Cirrhosis Due to HCV Genotype 1 or 4 Nonresponders to Previous Standard Therapy.
Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a
(360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated
liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a
standard dose treatment of both drugs.
(*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after
12 weeks in treatment or breakthrough viremia while on treatment.
Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a
and ribavirin plasma concentrations on early viral response (EVR) and sustained viral
response (SVR) in these patients.
Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from
several hospitals of the Servicio Andaluz de Salud will be enrolled.
The usual clinical and analytical follow up will be performed but additional blood samples
will be obtained for determination of interferon and ribavirin plasma levels. The primary
end point will be a sustained virologic response (defined as an undetectable serum HCV-RNA
after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4
weeks of treatment), early virological response (at 12 weeks), and end of treatment response
rates will be evaluated as well as their relationships with the plasma interferon an
ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and
tolerability of the studied medications will be evaluated by means of clinical adverse
events, physical examination and laboratory results. The evolution of liver fibrosis will be
evaluated comparing the basal and end of treatment results of transient elastometry.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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