A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration
研究概览
简要总结
A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected subjects.
详细描述
Efavirenz Pharmacokinetic evaluation supports once-daily dosing (T1/2 is 10-52 hours). The recommended dosage of efavirenz in combination with nucleoside reverse transcriptase inhibitor (NRTI) and/or protease inhibitor (PI) is 600mg orally, once daily.
In Thai populations, many ARV levels are very high. We believe that 600 mg efavirenz is too high for Thai people and would like to see the pharmacokinetic data and safety and efficacy of efavirenz at 400 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Age > 18 years of age or older with HIV-1 infection
- •Who are on stable PI-based highly active antiretroviral therapy and have HIV-1 RNA <50 copies/ml within 6 months.
- •No active opportunistic infection.
- •Sexually active subjects must be willing to use an effective form of birth control.
- •Able to provide written informed consent.
排除标准
- •Pregnant or breast-feeding females are excluded.
- •Inability to understand the nature and extent of the study and the procedures required.
- •ALT/ AST more than 5x upper limit
- •Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- •Use of concomitant medication that may interfere with the pharmacokinetics of efavienz
- •History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- •Active drug abuse
研究组 & 干预措施
1
400 mg EFV
干预措施: efavirenz (Drug)
2
600 mg EFV
干预措施: efavirenz (Drug)
结局指标
主要结局
Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration
时间窗: 6 weeks
次要结局
- Access efavirenz plasma level after discontinuation of this medication(4 weeks)