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临床试验/NCT00685191
NCT00685191已完成4 期

HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

Germans Trias i Pujol Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
15
试验地点
1
主要终点
Change in viral load from day 0 to 7

研究概览

简要总结

The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.

详细描述

First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.
  • Subjects initiating raltegravir plus another fully active antiretroviral drug.

排除标准

  • Pregnancy, or fertile women willing to be pregnant.
  • Active substance abuse or major psychiatric disease.

研究组 & 干预措施

1

Experimental

HIV-1-infected subjects initiating raltegravir-including salvage therapy

干预措施: Salvage antiretroviral therapy including raltegravir (Drug)

结局指标

主要结局

Change in viral load from day 0 to 7

时间窗: 1 week

次要结局

  • Intracellular levels of HIV-1 proviral DNA and LTR circles(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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