跳至主要内容
临床试验/EUCTR2007-005330-37-IT
EUCTR2007-005330-37-IT进行中(未招募)不适用

Pharmacokinetics of atazanavir at the dose of 300mg or 400mg in subjects with HIV-1 infection and non-decompensated hepatic cirrhosis (Child-Pugh A o B, Metavir F4), crossover study. - EPAZANAVIR-1

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2007年10月16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

  • > 18 years-old, able to give an informed consent.
  • Need to be treated with atazanavir.
  • Hepatic cirrhosis of any cause, Child-Pugh A o B, Metavir F4.
  • HIV-RNA < 100,000 copies/mL.
  • 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

  • NNRTI treatment at the moment of receiving atazanavir or need to include NNRTI or Tenofovir in the ARV regimen.
  • Active HIV-disease or possibility of a rapid deterioration.
  • Therapy with Interferons.
  • Hyperbilirubinemia > 3,5, ascitis or oedema.

研究者

发起方
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

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