NCT00046332已完成2 期
A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive 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
- 100
- 试验地点
- 24
- 主要终点
- Plasma HIV-1 RNA change from baseline by Day 11.
研究概览
简要总结
This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No prior HIV medications.
- •HIV infection with viral load >400-50,000 copies/mL.
- •CD4 cell count >50 cells/mm.
排除标准
- •Patients requiring medications that cannot be interrupted for the duration of the study.
- •Abnormal ECG or other chronic health conditions as noted on screening physical exam.
- •Previous participation in an experimental drug trial(s) within 30 days of the screening visit for this study.
结局指标
主要结局
Plasma HIV-1 RNA change from baseline by Day 11.
次要结局
- HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.
研究者
研究点 (24)
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