Pilot study randomised and open to compare the switch to trizivir against the previous treatment in chronic HIV-1 infected patients with liver cirrhosis secondary to Hepatitis C coinfectio
- Conditions
- Antiviral treatment of HIV-1 infected patients with liver cirrhosis secondary to Hepatitis C coinfection.
- Registration Number
- EUCTR2004-004060-70-ES
- Lead Sponsor
- Juan Gonzalez García
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients without present treatement for hepatitis C and without forecast to have it during the time of the study period
Age over 18 years.
Chronic HIV-1 infected patients
Highly active antiretroviral therapy based on two NRTI+PI or NNRTI stable at least ? 6 months.
Viral load (HIV) <50copies/ml at least for the last 6 months
Liver cirrhosis secondary to Hepatitis C virus infection
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) yes
F.1.3.1 Number of subjects for this age range
Insufficient prior treatment
Previous virological failure
Alcohol intake> 50 g per day
Hepatic decompensation in the last 6 months.
History of hipersensibility or previous adverse events to any of the drugs of the new regimen
Pregnant females/Lactation
HBC coinfected patients
Patients with C score on the Child- Pugh classification
Serum ALT 5-fold greater than the upper limit of the normal value
Patients with the possibility to receive a specific treatment for the HCV infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method