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Drug Interactions Between Echinacea Purpurea and Etravirine

HIV Clinical Trial

Official title:
DRUG INTERACTIONS BETWEEN ECHINACEA PURPUREA AND ETRAVIRINE

Clinical Trial Summary

The purpose of this clinical trial is to characterize drug interactions between one medicinal herb: Echinacea purpurea and the protease inhibitor etravirine.

Clinical Trial Description

Because of its CYP3A4 inducer activity in the liver but its inhibitor effect at the intestinal site, concomitant administration of Equinacea purpurea (a medicinal herb frequently used by HIV-infected patients) and etravirine (an HIV reverse transcriptase inhibitor) might result in clinically relevant pharmacokinetic drug interactions.

15 HIV-infected patients on stable antiretroviral therapy including etravirine at the dosage of 200 mg twice daily during at least 4 weeks will be enrolled. After their inclusion in the study, patients will receive Echinacea purpurea root (500 mg every 8 hours) in addition to their antiretroviral treatment, 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 an etravirine dose, and etravirine 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 NCT01347658
Study type Interventional
Source Fundacio Lluita Contra la SIDA
Contact
Status Completed
Phase N/A
Start date April 2011
Completion date August 2011
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