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Drug Interactions Between Echinacea Purpurea and Etravirine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier:
NCT01347658
First received: March 22, 2011
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
HIV
 Dietary Supplement: Echinacea purpurea
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DRUG INTERACTIONS BETWEEN ECHINACEA PURPUREA AND ETRAVIRINE

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundacio Lluita Contra la SIDA:

Primary Outcome Measures:
  • plasma concentration of etravirine. [ Time Frame: Change from baseline to day 14 ] [ Designated as safety issue: No ]
    plasma concentration of etravirine.


Secondary Outcome Measures:
  • Clearance (CL/F) [ Time Frame: Change from baseline to day 14 ] [ Designated as safety issue: No ]
  • Volume of distribution (V/F) [ Time Frame: Change from baseline to day 14 ] [ Designated as safety issue: No ]
  • Elimination half-life (t1/2) [ Time Frame: Change from baseline to day 14 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve during the dosing interval (AUC0-24) [ Time Frame: Change from baseline to day 14 ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: From baseline to day 28 ] [ Designated as safety issue: Yes ]
  • HIV Viral load in plasma [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
  • Number of patients with laboratory alterations [ Time Frame: From baseline to day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347658

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Fundacio Lluita Contra la SIDA
  More Information

No publications provided

Responsible Party: Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier: NCT01347658     History of Changes
Other Study ID Numbers: ECHI-ETRA
Study First Received: March 22, 2011
Last Updated: September 29, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Fundacio Lluita Contra la SIDA:
etravirine
Echinacea purpurea
interaction

ClinicalTrials.gov processed this record on June 18, 2013