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The purpose of this clinical trial is to characterize drug interactions between one medicinal herb: Echinacea purpurea and the protease inhibitor etravirine.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etravirine + echinacea | Experimental | etravirine + root of Echinacea purpurea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echinacea purpurea | Dietary Supplement | Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentration of etravirine. | plasma concentration of etravirine. | Change from baseline to day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL/F) | Change from baseline to day 14 | |
| Volume of distribution (V/F) | Change from baseline to day 14 | |
| Elimination half-life (t1/2) |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
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| ID | Term |
|---|---|
| C000718679 | Echinacea extract |
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| Change from baseline to day 14 |
| Area under the plasma concentration-time curve during the dosing interval (AUC0-24) | Change from baseline to day 14 |
| Number of patients with adverse events | From baseline to day 28 |
| HIV Viral load in plasma | Day 14 |
| Number of patients with laboratory alterations | From baseline to day 28 |