NCT00730223已完成1 期
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Pharmacokinetics of single dose nevirapine and single dose efavirenz
研究概览
简要总结
To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy African American men and women.
- •18-55 years of age.
- •Willing and able to provide written informed consent.
排除标准
- •Currently or recently (within the previous 30 days) received medications known or likely to be metabolized by, or interact wth the CYP450 enzymes.
- •Prior or current hepatic or psychiatric disease illness that in the judgment of the investigator would interfere in the study performance.
- •Active alcohol or illicit drug abuse use that in the judgment of the investigator would interfere in the study performance.
- •Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >1.5 X upper limit of normal.
- •Positive pregnancy test in women of childbearing potential.
结局指标
主要结局
Pharmacokinetics of single dose nevirapine and single dose efavirenz
时间窗: 5-6 weeks
次要结局
未报告次要终点
研究者
David Haas
Professor of Medicine
Vanderbilt University
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