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Clinical Trials/EUCTR2005-000203-34-ES
EUCTR2005-000203-34-ES
Active, not recruiting
Not Applicable

Open, multicenter and randomized study phase IV to evaluate the efficacy and safety of 24 weeks versus 48 weeks of treatment in patients with chronic hepatitis C genotype II and/or III coinfected with human inmunodeficiency virus. - 24 weeks vs. 48 weeks of treatment of coinfected HIV/HCV patients genotype II-III

Enrique Ortega González0 sites186 target enrollmentAugust 13, 2012
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ConditionsHepatitis CTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsCopegus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatitis C
Sponsor
Enrique Ortega González
Enrollment
186
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 13, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Enrique Ortega González

Eligibility Criteria

Inclusion Criteria

  • •patients in treatment with peginterferon alfa 2a and ribavirin which HCV\-RNA is undetectable at 24 weeks\- patients with RNA\-HCV positive and genotype II\-III at 44 weeks before the start of the 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 186
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients with HCV\-RNA positive after 24 weeks of treatment with peginterferon alfa 2a in combination with ribavirin \- patients with other different treatment to the study\- 3 or more weeks without treatment between the end of the standard treatment and the inclusion of the trial

Outcomes

Primary Outcomes

Not specified

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