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临床试验/NCT00703898
NCT00703898已完成4 期

Durability of Stavudine, Lamivudine and Nevirapine Among Advanced HIV-1 Infected Patients With/Without Prior Co-Administration of Rifampicin: A 144-Week Prospective Study

Bamrasnaradura Infectious Diseases Institute2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2004年11月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
140
试验地点
2
主要终点
number of patients with undetectable plasma HIV-1 viral load

研究概览

简要总结

Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. In addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.

研究设计

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

入排标准

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

入选标准

  • HIV-infected individuals ≥15 years of age
  • CD4 cell count <350 cells/mm3
  • Willing to participate and give consent form

排除标准

  • previous antiretroviral therapy
  • pregnancy
  • receiving a medication that has drug-drug interactions with NVP or RFP
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >5 times of upper limit of normal range

结局指标

主要结局

number of patients with undetectable plasma HIV-1 viral load

时间窗: 240 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (2)

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