Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
NCT Number: NCT01347658
The purpose of this clinical trial is to characterize drug interactions between one medicinal herb: Echinacea purpurea and the protease inhibitor etravirine.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Badalona, Barcelona, 08916, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.
Time frame: Change from baseline to day 14
plasma concentration of etravirine.
Time frame: Change from baseline to day 14
Time frame: Change from baseline to day 14
Time frame: Change from baseline to day 14
Time frame: Change from baseline to day 14
Time frame: From baseline to day 28
Time frame: Day 14
Time frame: From baseline to day 28
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Other
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