Drug Interactions Between Echinacea Purpurea and Etravirine
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||DRUG INTERACTIONS BETWEEN ECHINACEA PURPUREA AND ETRAVIRINE|
- plasma concentration of etravirine. [ Time Frame: Change from baseline to day 14 ]plasma concentration of etravirine.
- Clearance (CL/F) [ Time Frame: Change from baseline to day 14 ]
- Volume of distribution (V/F) [ Time Frame: Change from baseline to day 14 ]
- Elimination half-life (t1/2) [ Time Frame: Change from baseline to day 14 ]
- Area under the plasma concentration-time curve during the dosing interval (AUC0-24) [ Time Frame: Change from baseline to day 14 ]
- Number of patients with adverse events [ Time Frame: From baseline to day 28 ]
- HIV Viral load in plasma [ Time Frame: Day 14 ]
- Number of patients with laboratory alterations [ Time Frame: From baseline to day 28 ]
|Study Start Date:||April 2011|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: Etravirine + echinacea
etravirine + root of Echinacea purpurea
Dietary Supplement: Echinacea purpurea
Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347658
|Hospital Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|