NCT01046890已完成4 期
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
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
- plasma concentration of darunavir and ritonavir
研究概览
简要总结
The purpose of this clinical trial is to characterize drug interactions between one medicinal herb widely used by HIV infected patients: Echinacea sp. and the protease inhibitor darunavir/ritonavir.
详细描述
15 patients on antiretroviral therapy with darunavir/ritonavir 600/100 mg twice a day during four weeks will be recruited. The patients will receive treatment with Echinacea purpurea for 14 days, 500 mg every 6 hours. A 12 hour pharmacokinetic curve will be obtained at baseline and on day 14.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients infected with HIV-1 (at least one documented positive Western-Blot).
- •Age =/+ 18 years.
- •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.
- •Voluntary written informed consent.
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).
- •Pregnancy or lactation
研究组 & 干预措施
darunavir/ritonavir + root of Echinacea purpurea
Experimental
darunavir/ritonavir + root of Echinacea purpurea
干预措施: Echinacea (Drug)
结局指标
主要结局
plasma concentration of darunavir and ritonavir
时间窗: DAY 14
次要结局
- Volume of distribution (V/F)(DAY 14)
- Elimination half-life (t1/2)(DAY 14)
- Clearance (CL/F)(DAY 14)
- Area under the plasma concentration-time curve during the dosing interval(DAY 14)
- Adverse events and laboratory alterations(DAY 14)
- HIV Viral load in plasma(DAY 14)
研究者
研究点 (1)
Loading locations...
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