跳至主要内容
临床试验/EUCTR2004-004060-70-ES
EUCTR2004-004060-70-ES进行中(未招募)不适用

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

Juan Gonzalez García0 个研究点开始时间: 2005年5月18日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Juan Gonzalez García

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