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 coinfection

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: 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 Name: Trizivir Product Name: Trizivir Pharmaceutical Form: Tablet INN or Proposed INN: lamivudina Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: Trizivir Product Name: Trizivir Pharmaceutical Form: Tablet INN or Proposed INN: zidovudina Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ CONDITION: Antiviral treatment of HIV‐1 infected patients with liver cirrhosis secondary to Hepatitis C coinfection. PRIMARY OUTCOME: 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.; Primary end point(s): Proportion of adverse events and/or withdrawls due to trizivir treatment. 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.; 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) <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
Epistemonikos ID: 76715aa1e5a1ce68a47200e2ae3b44176fee6182
First added on: Aug 21, 2024