The Effect of Rifapentine on Plasma Concentrations of Raltegravir
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Raltegravir pharmacokinetics (Cmin and AUC)
研究概览
简要总结
The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.
详细描述
Primary Objective
To compare the pharmacokinetics parameter values (geometric mean Cmin and AUC) of raltegravir at 400 mg q12h alone to raltegravir at 400 mg q12h co-administered in combination with rifapentine 900 mg once weekly, and to raltegravir at 400 mg q12h co-administered in combination with rifapentine 600 mg per day, 5 days per week.
Secondary Objective
To assess the tolerability and safety of concomitant administration of raltegravir and rifapentine in healthy volunteers.
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-nursing female age > 18 years in good health
- •Provision of informed consent for the study.
- •HIV-uninfected. A prior negative HIV test (ELISA) must be obtained before enrollment.
- •Willingness to have PK sampling in a day clinic or to be admitted overnight to a hospital on three occasions.
- •Women of child-bearing potential must agree to practice an adequate method of birth control during the study and for 30 days after the last dose of study medication. Barrier methods of contraception or abstinence from sexual activity are satisfactory methods of birth control.
- •Karnofsky score ≥
- •Laboratory screening before enrollment:
- •Hematocrit > 30 percent (most recent value)
- •AST < 2 times the upper limit of normal
- •ALT < 2 times the upper limit of normal
- •Bilirubin < 2 times the upper limit of normal
- •Creatinine < 1.5 times the upper limit of normal
- •Negative urine drug screen
排除标准
- •Pregnancy or breast-feeding.
- •Use of a medication or food that has the potential to alter the concentrations of raltegravir or rifapentine, within the 14 days prior to or during the periods of pharmacokinetic monitoring.
- •Known intolerance to raltegravir or rifamycin antibiotics or prior use in the last 30 days.
- •Weight less than 46 kg or greater than 102 kg.
- •Prior gastrointestinal surgery.
- •Infection with Hepatitis B or Hepatitis C by serologies.
- •Co-morbidity for which concomitant, current medications are taken regularly. If concomitant medications are taken intermittently, these medications should not have potential to alter the concentrations of raltegravir or rifapentine.
- •Current imprisonment
研究组 & 干预措施
raltegravir and rifapentine
Concomitant administration of raltegravir and rifapentine in healthy volunteers
干预措施: Raltegravir and rifapentine (Drug)
结局指标
主要结局
Raltegravir pharmacokinetics (Cmin and AUC)
时间窗: Eight weeks
次要结局
- Tolerability and safety of concomitant raltegravir and rifapentine administration(Eight weeks)