Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
关键词
抽象
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.
日期
| 最后验证: | 11/30/2019 |
| 首次提交: | 01/10/2010 |
| 提交的预估入学人数: | 01/10/2010 |
| 首次发布: | 01/11/2010 |
| 上次提交的更新: | 12/02/2019 |
| 最近更新发布: | 12/03/2019 |
| 实际学习开始日期: | 12/31/2009 |
| 预计主要完成日期: | 02/28/2010 |
| 预计完成日期: | 03/31/2010 |
状况或疾病
干预/治疗
Drug: darunavir/ritonavir + root of Echinacea purpurea
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: darunavir/ritonavir + root of Echinacea purpurea darunavir/ritonavir + root of Echinacea purpurea | Drug: darunavir/ritonavir + root of Echinacea purpurea darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Patients infected with HIV-1 (at least one documented positive Western-Blot). 2. Age =/+ 18 years. 3. Patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 mg twice daily for at least 4 weeks 4. HIV viral load in plasma <50 copies / mL 5. Absence of acute infections and / or tumors in the three months prior to inclusion. 6. Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments. 7. Voluntary written informed consent. Exclusion Criteria: 1. 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. 2. Active alcohol consumption (> 50 g / day) or illicit drugs (except cannabis). 3. Pregnancy or lactation |
结果
主要结果指标
1. plasma concentration of darunavir and ritonavir [DAY 14]
次要成果指标
1. Clearance (CL/F) [DAY 14]
2. Volume of distribution (V/F) [DAY 14]
3. Elimination half-life (t1/2) [DAY 14]
4. Area under the plasma concentration-time curve during the dosing interval [DAY 14]
5. Adverse events and laboratory alterations [DAY 14]
6. HIV Viral load in plasma [DAY 14]
