HIV Infections Clinical Trial
Official title:
Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4
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. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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