24 weeks vs. 48 weeks of treatment of coinfected HIV/HCV patients genotype II-III
- Conditions
- Hepatitis CTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2005-000203-34-ES
- Lead Sponsor
- Enrique Ortega González
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 186
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of 24 weeks vs. 48 weeks of treatment in coinfected patients HIV/VHC.;Secondary Objective: To evaluate the safety;Primary end point(s): percentage of patients with HCV-RNA undetectable at 24 week of the study;Timepoint(s) of evaluation of this end point: 24 and 48 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To asses the safety of both treatment periods;Timepoint(s) of evaluation of this end point: 24 o 48 weeks