Drug Interactions Between Echinacea Purpurea and Etravirine

DRUG INTERACTIONS BETWEEN ECHINACEA PURPUREA AND ETRAVIRINE

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

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Dietary supplement: Echinacea purpurea

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Patients infected with HIV-1 (at least one documented positive Western-Blot).
2. Age 18 years or more.
3. Patients receiving antiretroviral therapy including etravirine at the approved dose of 200 mg twice daily for at least 4 weeks
4. HIV viral load in plasma <50 copies / mL
5. Absence of acute infections and / or tumors in the three months prior to inclusion.
6. Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.
7. Voluntary written informed consent.

Exclusion criteria:

1. Any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction.
2. Antiretroviral regimen including drugs ritonavir or atazanavir (CYP3A4 inhibitors)
3. Concomitant treatment with drugs inductors of CYP3A4 (rifampicin, fenitoin, carbamazepin, ...)
4. Active alcohol consumption (> 50 g / day) or illicit drugs (except cannabis).
5. Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etravirine + echinacea; etravirine + root of Echinacea purpurea	Dietary supplement: Echinacea purpurea; Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma concentration of etravirine.	plasma concentration of etravirine.	Change from baseline to day 14

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (Estimate): May 4, 2011

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: interaction; etravirine; Echinacea purpurea
• Other Study ID Numbers: ECHI-ETRA