Drug Interactions Between Silimarine And Darunavir/Ritonavir
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir
研究概览
简要总结
This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.
详细描述
The silimarine is the main component of milk thistle (Sylibum marianum), a medicinal herb which, due to its attributed hepatoprotective properties, is widely used by HIV infected patients
15 patients on stable antiretroviral therapy including darunavir/ritonavir 600/100 mg twice a day during four weeks will be enrolled. After their inclusion in the study, patients will receive treatment with silimarine (150 mg every 8 hours) from day 1 until two weeks later (day 14). On days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the administration of darunavir/ritonavir, and darunavir and ritonavir concentrations in plasma will be determined by high performance liquid chromatography using a validated method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 mg twice daily for at least 4 weeks
- •HIV viral load in plasma <50 copies / mL
- •Absence of acute infections and / or tumors in the three months prior to inclusion.
- •Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.
排除标准
- •Any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction.
- •Active alcohol consumption (> 50 g / day) or illicit drugs (except cannabis).
研究组 & 干预措施
Silimarine
darunavir + ritonavir + silimarine
干预措施: Silimarine (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir
时间窗: DAY 0, day 14
次要结局
- Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir(DAY 0, day 14)
- Darunavir and ritonavir clearance (CL/F)(DAY 0, day 14)
- Darunavir and ritonavir volume of distribution (V/F)(DAY 0, day 14)
- Darunavir and ritonavir elimination half-life (t1/2) of darunavir and ritonavir(DAY 0, day 14)
- Darunavir and ritonavir trough concentration in plasma(DAY 0, day 14)
- Adverse events and laboratory abnormalities(DAY 0, 14, 28)