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
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
- 否
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
研究点 (2)
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