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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021159-25 |
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| Name | Class |
|---|---|
| IrsiCaixa | OTHER |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
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This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silimarine | Experimental | darunavir + ritonavir + silimarine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silimarine | Drug | darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir | DAY 0, day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change from day 0 in Darunavir and ritonavir clearance at day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lluita contra la Sida Foundation, HIV Unit | Badalona | Barcelona | 08916 | Spain |
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| DAY 0, day 14 |
| Darunavir and ritonavir volume of distribution (V/F) | Change from day 0 in Darunavir and ritonavir volume of distribution at day 14 | 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 | Number of patients with adverse events and laboratory abnormalities grade 3 or 4 | DAY 0, 14, 28 |