Antiviral treatment of HIV-1 infected patients with liver cirrhosis secondary to Hepatitis C coinfection.
Conditions
Interventions
Trade Name: Trizivir
Product Name: Trizivir
Pharmaceutical Form: Tablet
INN or Proposed INN: abacavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Na
Sponsors
Juan Gonzalez García
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To know the security and tolerability of Trizivir in patients with liver cirrhosis secondary to hepatitis C infection in HIV infected patients who receive a stable highly active antiretroviral therapy based on two NRTI+PI or NNRTI. To investigate if the switch to Trizivir decreases the risk of progression of the hepatic illness without increasing the risk of progression of the HIV-1 infection in patients with HIV-1 infection and liver cirrhosis secondary to Hepatitis C coinfection who receive a stable highly active antiretroviral therapy based on two NRTI+PI or NNRTI. ;Secondary Objective: To compare the frecuency and the time until the apareance of adverse events and/or withdrawls between both groups of treatment. To compare among both groups of treatment the number of patients that progress to C category of the CDC classification system for HIV-infected patients. To measure and to compare the frequency of patients with indetectable viral load (ARN VIH <50 c /ml) at month 24. To measure the changes from baseline in CD4 cell count through 24 months and to compare them among the two groups of treatment. To measure laboratory changes from baseline through 24 months and to compare them among the two groups of treatment. To measure the changes on Child-Pugh and on Meld classification from baseline through the 24 months. To measure changes in the viral load of HCV from baseline through the month 24. To know the correlation between the phamacokinetic levels of zidovudine, lamivudine and abacavir (Trizivir) and the Child-Pugh score. ;Primary end point(s): Proportion of adverse events and/or withdrawls due to trizivir treatment. | — |
Countries
Spain
Outcome results
None listed