NCT00398125已完成2 期
A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 13
- 主要终点
- Amount of drug in blood
研究概览
简要总结
To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Amount of drug in blood
时间窗: on Days 1 and 10.
Change in viral load
时间窗: from Day 1 to Day 11
次要结局
- Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients(throughout the study)
研究者
研究点 (13)
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