Drug Interactions Between Echinacea Purpurea and Etravirine
DRUG INTERACTIONS BETWEEN ECHINACEA PURPUREA AND ETRAVIRINE
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this clinical trial is to characterize drug interactions between one medicinal herb: Echinacea purpurea and the protease inhibitor etravirine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Apr 2011
Shorter than P25 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedNovember 14, 2019
September 1, 2011
4 months
March 22, 2011
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plasma concentration of etravirine.
plasma concentration of etravirine.
Change from baseline to day 14
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Etravirine + echinacea
EXPERIMENTALetravirine + root of Echinacea purpurea
Interventions
Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.
Eligibility Criteria
You may qualify if:
- 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
- Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.
- Voluntary written informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
May 4, 2011
Study Start
April 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 14, 2019
Record last verified: 2011-09