跳至主要内容
临床试验/NCT00805857
NCT00805857撤回不适用

SCOLTA: SURVEILLANCE COHORT LONG-TERM TOXICITY ANTIRETROVIRALS

Boehringer Ingelheim0 个研究点开始时间: 2008年6月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
To evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV infected patients enrolled in Tipranavir cohort and to identify possible risk factors

研究概览

简要总结

The SCOLTA project is a system for online surveying of adverse events to recently commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events reactions arising during any antiretroviral treatment.Aim of the proposed study is:

  1. to evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV-infected patients enrolled in the SCOLTA project Tipranavir cohort and to identify possible risk factors
  2. the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients > 18 years old HIV infected treated with tipranavir

排除标准

  • 未提供

结局指标

主要结局

To evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV infected patients enrolled in Tipranavir cohort and to identify possible risk factors

时间窗: 48wks

次要结局

  • the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason(48wks)

研究者

申办方类型
Industry

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