NCT00397566撤回2 期
Randomized, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-707035 in HIV-1 Infected Subjects
Bristol-Myers Squibb0 个研究点开始时间: 2007年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.
研究概览
简要总结
The purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1-infected subjects with CD4+ lymphocyte count ≥ 200 cells/mm3 and with plasma HIV-1 RNA ≥ 5000 copies/mL who have not been on antiretroviral (ARV) therapy for ≥ 8 weeks or who are naive to ARV, and who are otherwise medically stable as determined by medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. In addition, subjects must have had no prior exposure to the Integrase Inhibitor class of compounds.
- •Female subjects must not be nursing, pregnant, or of childbearing potential
排除标准
- 未提供
结局指标
主要结局
To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.
次要结局
- Safety and tolerability with 10 days of dosing
- Effect on QTc intervals
- Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte
- Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects
- Assess relationship of EC90 and exposures of BMS-707035 to the magnitude of change in viral loads
- Assess plasma protein binding and intracellular concentration in PBMC for BMS-707035
研究者
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