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Drug Interactions Between Echinacea Purpurea and Etravirine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347658
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : September 30, 2011
Information provided by (Responsible Party):
Fundacio Lluita Contra la SIDA

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

Condition or disease Intervention/treatment Phase
HIV Dietary Supplement: Echinacea purpurea Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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.

Primary Outcome Measures :
  1. plasma concentration of etravirine. [ Time Frame: Change from baseline to day 14 ]
    plasma concentration of etravirine.

Secondary Outcome Measures :
  1. Clearance (CL/F) [ Time Frame: Change from baseline to day 14 ]
  2. Volume of distribution (V/F) [ Time Frame: Change from baseline to day 14 ]
  3. Elimination half-life (t1/2) [ Time Frame: Change from baseline to day 14 ]
  4. Area under the plasma concentration-time curve during the dosing interval (AUC0-24) [ Time Frame: Change from baseline to day 14 ]
  5. Number of patients with adverse events [ Time Frame: From baseline to day 28 ]
  6. HIV Viral load in plasma [ Time Frame: Day 14 ]
  7. Number of patients with laboratory alterations [ Time Frame: From baseline to day 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01347658

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

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Responsible Party: Fundacio Lluita Contra la SIDA Identifier: NCT01347658     History of Changes
Other Study ID Numbers: ECHI-ETRA
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: September 30, 2011
Last Verified: September 2011
Keywords provided by Fundacio Lluita Contra la SIDA:
Echinacea purpurea
Additional relevant MeSH terms:
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Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents