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Two Different Treatments 24 vs 48 Weeks Chronic Hepatitis C Genotypes 2 and/or 3 in co-Infected HIV-HCV

NCT00611819 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2008-02-11

No results posted yet for this study

Summary

The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment.

Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment.

In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%.

In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks.

In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.

Conditions

  • Chronic Hepatitis C
  • Co-Infection HIV-HCV

Interventions

DRUG

Peg interferon + Ribavirin

Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks

DRUG

Peg interferon + Ribavirin

Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Enrique Ortega, Dr · Hospital General Universitario de Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-04-30
Completion
2008-12-31

Countries

  • Spain

Study Locations

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Entities

Companies

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 NCT00611819 on ClinicalTrials.gov