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Completed

NCT Number: NCT01347658

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.

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Key information

Conditions

HIV

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Antiretroviral regimen including drugs ritonavir or atazanavir (CYP3A4 inhibitors)
  • Concomitant treatment with drugs inductors of CYP3A4 (rifampicin, fenitoin, carbamazepin, ...)
  • Active alcohol consumption (> 50 g / day) or illicit drugs (except cannabis).
  • Pregnancy or lactation

Treatment and study plan

Echinacea purpurea

Dietary Supplement

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

Primary outcomes

  1. plasma concentration of etravirine.

    Time frame: Change from baseline to day 14

    plasma concentration of etravirine.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 4, 2011
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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