Clinical trial NCT01347658: Drug Interactions Between Echinacea Purpurea and Etravirine
Official title: DRUG INTERACTIONS BETWEEN ECHINACEA PURPUREA AND ETRAVIRINE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: etravirine
Echinacea purpurea
interaction
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: plasma concentration of etravirine.
timeFrame: Change from baseline to day 14
Secondary outcomes:
measure: Clearance (CL/F)
timeFrame: Change from baseline to day 14
measure: Volume of distribution (V/F)
timeFrame: Change from baseline to day 14
measure: Elimination half-life (t1/2)
timeFrame: Change from baseline to day 14
measure: Area under the plasma concentration-time curve during the dosing interval (AUC0-24)
timeFrame: Change from baseline to day 14
measure: Number of patients with adverse events
timeFrame: From baseline to day 28
measure: HIV Viral load in plasma
timeFrame: Day 14
measure: Number of patients with laboratory alterations
timeFrame: From baseline to day 28
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
Study officials:
References: