NCT00564772已完成4 期
An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- drug levels of lopinavir, ritonavir, raltegravir
研究概览
简要总结
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.
详细描述
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects. The initial cohort, to be studied simultaneously, will be 15 subjects with intention to collect complete data from 12 subjects. Replacements will be subsequently enrolled if necessary. Subjects will be reimbursed.
The periods will be
- Period 1: Raltegravir (RAL) 400 mg q12h for 4 days (7 doses of RAL).
- Period 2: Kaletra 200 mg 2 pills bid for 10 days (19 doses of Kaletra).
- Period 3: both regimens for 4 days (7 doses of both drugs). All morning doses will be observed at Prism Research, Inc. Evening doses will be distributed each morning. 12 hour PK studies will be done on the last day of each period. Specimens will be obtained 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours after the morning dose of the last dosing day of each period.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, male or female, age 18-
- •Anti-HIV, anti-HCV, HBsAg negative.
- •Normal history and physical at screening.
- •Normal complete blood count, creatinine and ALT at screening.
- •Negative urine pregnancy test at screening.
- •BMI 18-30.
排除标准
- •Donated blood in the month before Day
- •Participated in another research study in the month before Day
- •Tobacco use in the 3 months before Day 1, unwillingness to avoid tobacco use during the study.
- •Use of any illegal drug in the year before Day 1, positive drug screen for an illegal drug at screening.
- •Unwillingness to restrict coffee use to 6 or fewer cups of coffee during the study.
- •Unwillingness on the part of fertile female subjects to be abstinent or to use two effective birth control methods, one of which is a barrier method, for any vaginal intercourse.
- •Unwillingness to avoid use of any prescribed medication during the study
- •Allergy to RAL, lopinavir or ritonavir.
研究组 & 干预措施
single arm
Experimental
all subjects dosed the same
干预措施: Raltegravir, lopinavir, ritonavir (Drug)
结局指标
主要结局
drug levels of lopinavir, ritonavir, raltegravir
时间窗: 2 months
次要结局
- safety(2 months)
研究者
研究点 (1)
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