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Drug Interactions Between Silimarine and Darunavir/Ritonavir

HIV Clinical Trial

Official title:
Drug Interactions Between Silimarine And Darunavir/Ritonavir

Clinical Trial Summary

This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01346982
Study type Interventional
Source Fundacio Lluita Contra la SIDA
Contact
Status Completed
Phase Phase 4
Start date March 2011
Completion date July 2011
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