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Clinical Trials/EUCTR2004-004948-45-ES
EUCTR2004-004948-45-ES
Active, not recruiting
Not Applicable

Open, multicenter and randomized study phase IV to evaluate the efficacy and safety of 24 weeks more of treatment in patients with chronic hepatitis C genotype 1 and/or 4 co-infected with human inmmunodeficiency virus - Treatment of co-infected HIV/HCV patients genotype 1/4 24 weeks more than standar duration

José Hernández-Quero. Hospital Clínico San Cecilio0 sitesMay 24, 2006
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ConditionsChronic hepatitis C
DrugsPegasys 180 mcgCopegusPegasys 135 mcg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic hepatitis C
Sponsor
José Hernández-Quero. Hospital Clínico San Cecilio
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 24, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
José Hernández-Quero. Hospital Clínico San Cecilio

Eligibility Criteria

Inclusion Criteria

  • •\- Patients in treatment with peginterferon alfa\-2a and ribavirin which HCV\-RNA is undetectable at 48 weeks.
  • •\- Patients with RNA\-HCV positive and genotype 1/4 at 44 weeks before the start of study.
  • •\- HIV positive
  • •\- AIDS stable
  • •\- Pregnancy test negative
  • •\- Patient authorization to participate in the study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •\- Patients with HCV\-RNA positive after 44 weeks of treatment with peginterferon alfa\-2a in combination with ribavirin
  • •\- Patients with other different treatment to the study.
  • •\- 3 o more weeks without treatment between the end of the standard treatment and the inclusion in the trial.

Outcomes

Primary Outcomes

Not specified

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