An interventional study of Echinacea purpurea in HIV, sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia. Completed at 1 site in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-11-14.
Sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Not applicable, Interventional, and Treatment
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.
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia is the lead sponsor of 44 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
etravirine + root of Echinacea purpurea
Dietary Supplement: Echinacea purpurea
Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.
plasma concentration of etravirine.
plasma concentration of etravirine.
Time frame: Change from baseline to day 14
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
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia