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Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4

NCT00612755 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2008-02-12

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections
  • Hepatitis C

Interventions

DRUG

Peginterferon alfa-2a + ribavirin

Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks

Sponsors & Collaborators

  • Hospital Clinico Universitario San Cecilio

    lead OTHER

Principal Investigators

  • José Hernández-Quero, Dr · Hospital Clínico Universitario San Cecilio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-01-31
Completion
2008-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00612755 on ClinicalTrials.gov