NCT01347658

Drug Interactions Between Echinacea Purpurea and Etravirine

DRUG INTERACTIONS BETWEEN ECHINACEA PURPUREA AND ETRAVIRINE

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• HIV

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Echinacea purpurea	Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-05-04
• Last updated: 2019-11-14

Locations

1 site across 1 country: Spain