Pilot, open, multicenter, phase IV Clinical Trial to evaluate safety and efficacy in treatment with peginterferon alfa-2a plus ribavirin in VIH patients with advanced immunosupression and chronic hepatopathy secondary to hepatitis C virus. - Treatment with PEG-IFN alfa 2a plus RBV in VIH patients with advanced immunosupression & hepatopathy
- Conditions
- ¨Hepatitis C Crónica
- Registration Number
- EUCTR2005-002452-17-ES
- Lead Sponsor
- Hospital Universitario de Valme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
>18 years CD4+ levels between 50-250 mm3 during at least 48 weeks before the beginning of the study Indetectable VC during 48 weeks before the beginning the study Pregnancy test negative in urine during 24 h. before the first dose Acceptance of written informed consent - BEFORE TREATMENT Chronic hepatitis serologic evidence with anti-HCV antibodies test Chronic hepatopathy consisting in a biopsy HIV-1 serologic evidence
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Virologic failure or clinic events of AIDS 48 weeks before treatment Pregnant or in lactation women/couples Decompensated cirrhosis patients Treated with any experimental pharmaco Treated with D4T/DDI Positive test for immunoglobulines Other hepatic diseases associated Blood alterations-analitical alterations Evidence of hepatocarcinome or conditions of decompensated hepatic disease Severe psichiatric disease, immunologic disease history, chronic disease with functional limitation, significative cardiac disease history, thyroide related history, neoplasy (with treatment or sistemic immunomodulator) Concomitant medication with rifampicine, pirazinamide, isoniazide Drug use or excesive alcohol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate security of treatment with peginterferon alfa 2a in combination with ribavirin in VIH patients coinfected with hepatitis C with CD4 low levels ;Secondary Objective: To evaluate the efficacy of treatment with peginterferon alfa 2a in combination with ribavirin in VIH patients coinfected with hepatitis C with CD4 low levels;Primary end point(s): Security: 1: percentage of patients with treatment interruption with peginterferon alfa 2a and ribavirin during the study 2: AIDS diagnosed clinic events CD4+ cells levels during the study Adverse events in general Hepatic decompensation and deaths Requiring preventive treatment for oportunist processes during treatment EFICACY Percentage of patients with VSR with peginterferon alfa 2a and ribavirin
- Secondary Outcome Measures
Name Time Method