NCT00384904已完成4 期
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects
Bristol-Myers Squibb3 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Atazanavir plasma drug concentrations
研究概览
简要总结
The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²
- •Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA <400 copies/mL and have CD4 count >200 cells/mm³
排除标准
- 未提供
研究组 & 干预措施
A1
No Intervention
干预措施: Atazanavir/Ritonavir (Drug)
A2
Experimental
干预措施: Atazanavir/Ritonavir + Famotidine (Drug)
A3
Experimental
干预措施: Atazanavir/Ritonavir + Famotidine (Drug)
B1
No Intervention
干预措施: Atazanavir/Ritonavir (Drug)
B2
Experimental
干预措施: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine (Drug)
B3
Experimental
干预措施: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine (Drug)
结局指标
主要结局
Atazanavir plasma drug concentrations
时间窗: on days 10, 11, 17, 18, 24 and 25
次要结局
- Ritonavir plasma drug concentrations(on days 10, 11, 17, 18, 24 and 25)
- Safety measures: Physical examinations
- ECGs(entry and discharge)
- laboratory tests including, liver and renal function(entry, discharge and days 11, 18)
- CD4 count(discharge)
- HIV viral load(entry and discharge)
研究者
研究点 (3)
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