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

March 22, 2011
September 29, 2011
April 2011
August 2011   (final data collection date for primary outcome measure)
plasma concentration of etravirine. [ Time Frame: Change from baseline to day 14 ] [ Designated as safety issue: No ]
plasma concentration of etravirine.
Same as current
Complete list of historical versions of study NCT01347658 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Dietary Supplement: Echinacea purpurea
Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.
Experimental: Etravirine + echinacea
etravirine + root of Echinacea purpurea
Intervention: Dietary Supplement: Echinacea purpurea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01347658
ECHI-ETRA
No
Fundacio Lluita Contra la SIDA
Fundacio Lluita Contra la SIDA
Not Provided
Not Provided
Fundacio Lluita Contra la SIDA
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP