HIV Infections Clinical Trial
Official title:
Efficacy of Low Dose Pegylated Interferon-α 2a Plus Ribavirin for the Treatment of Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients.
Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as
effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected
patients.
Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg
weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an
undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic
hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected
patients in real use conditions.
Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration
of 118 weeks in which 71 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 wall 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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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