Drug Interactions Between Silimarine and Darunavir/Ritonavir
Ключевые слова
абстрактный
Описание
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.
Даты
| Последняя проверка: | 08/31/2011 |
| Первый отправленный: | 04/17/2011 |
| Предполагаемая регистрация отправлена: | 05/02/2011 |
| Первое сообщение: | 05/03/2011 |
| Последнее обновление отправлено: | 11/10/2019 |
| Последнее обновление опубликовано: | 11/13/2019 |
| Фактическая дата начала исследования: | 02/28/2011 |
| Предполагаемая дата завершения начальной школы: | 06/30/2011 |
| Предполагаемая дата завершения исследования: | 06/30/2011 |
Состояние или болезнь
Вмешательство / лечение
Drug: Silimarine
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| Experimental: Silimarine darunavir + ritonavir + silimarine | Drug: Silimarine darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours) |
Критерии приемлемости
| Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
| Полы, имеющие право на обучение | All |
| Принимает здоровых добровольцев | да |
| Критерии | Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
Результат
Основные показатели результатов
1. Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir [DAY 0, day 14]
Меры вторичного результата
1. Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir [DAY 0, day 14]
2. Darunavir and ritonavir clearance (CL/F) [DAY 0, day 14]
3. Darunavir and ritonavir volume of distribution (V/F) [DAY 0, day 14]
4. Darunavir and ritonavir elimination half-life (t1/2) of darunavir and ritonavir [DAY 0, day 14]
5. Darunavir and ritonavir trough concentration in plasma [DAY 0, day 14]
6. Adverse events and laboratory abnormalities [DAY 0, 14, 28]
