Drug Interactions Between Echinacea Purpurea and Etravirine

HIV Clinical Trial

Official title:

DRUG INTERACTIONS BETWEEN ECHINACEA PURPUREA AND ETRAVIRINE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347658
• Other study ID #: ECHI-ETRA
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Fundacio Lluita Contra la SIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacio Lluita Contra la SIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentration of etravirine.	plasma concentration of etravirine.	Change from baseline to day 14
Secondary	Clearance (CL/F)		Change from baseline to day 14
Secondary	Volume of distribution (V/F)		Change from baseline to day 14
Secondary	Elimination half-life (t1/2)		Change from baseline to day 14
Secondary	Area under the plasma concentration-time curve during the dosing interval (AUC0-24)		Change from baseline to day 14
Secondary	Number of patients with adverse events		From baseline to day 28
Secondary	HIV Viral load in plasma		Day 14
Secondary	Number of patients with laboratory alterations		From baseline to day 28