Drug Interactions Between Echinacea Purpurea and Etravirine

Not Applicable

Completed

• Conditions: HIV
• Interventions: Dietary Supplement: Echinacea purpurea

• Registration Number: NCT01347658
• Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Brief 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.

Study Timeline

• Study First Submitted: 2011-03-22
• Study Start: 2011-04
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-09
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etravirine + echinacea	Echinacea purpurea	etravirine + root of Echinacea purpurea

Primary Outcome Measures

Name	Time	Method
plasma concentration of etravirine.	Change from baseline to day 14	plasma concentration of etravirine.

Secondary Outcome Measures

Name	Time	Method
Elimination half-life (t1/2)	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
HIV Viral load in plasma	Day 14
Clearance (CL/F)	Change from baseline to day 14
Volume of distribution (V/F)	Change from baseline to day 14
Number of patients with adverse events	From baseline to day 28
Number of patients with laboratory alterations	From baseline to day 28

Trial Locations

Locations (1)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain