NCT01000818已完成1 期
An Open-Label, 3-Period, Fixed-Sequence Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 Pharmacokinetics in HIV-Infected Patients on a Stable MK0518-Containing Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
研究概览
简要总结
An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is Human immunodeficiency virus (HIV) positive
- •Patient is taking an MK0518 (Raltegravir) containing regimen
- •Patient has not had any changes to his/her antiviral regimen in the last 2 weeks
- •Patient who is of reproductive potential agrees to use an acceptable method of birth control
- •Patients baseline health is stable
排除标准
- •Patient has a history of stroke or chronic seizures.
- •Patient has a history of gastric bypass surgery
- •Patient is pregnant of breastfeeding
- •Patient consumes excessive amounts of caffeinated beverages daily
- •Patient has had major surgery, donated blood, or participated in another investigational study in the past 4 weeks
研究组 & 干预措施
Period 1
Experimental
MK0518
干预措施: MK0518 (Raltegravir) (Drug)
Period 2
Experimental
famotidine + MK0518
干预措施: MK0518 (Raltegravir) (Drug)
Period 2
Experimental
famotidine + MK0518
干预措施: famotidine (Drug)
Period 3
Experimental
omeprazole + MK0518
干预措施: MK0518 (Raltegravir) (Drug)
Period 3
Experimental
omeprazole + MK0518
干预措施: omeprazole (Drug)
结局指标
主要结局
Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
时间窗: 12 hours postdose
Area Under the Plasma Concentration-Time Curve and peak concentration
次要结局
未报告次要终点
研究者
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