Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

Study Overview
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Brief Summary
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The purpose of this clinical trial is to characterize drug interactions between one medicinal herb widely used by HIV infected patients: Echinacea sp. and the protease inhibitor darunavir/ritonavir.

Detailed Description
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15 patients on antiretroviral therapy with darunavir/ritonavir 600/100 mg twice a day during four weeks will be recruited. The patients will receive treatment with Echinacea purpurea for 14 days, 500 mg every 6 hours. A 12 hour pharmacokinetic curve will be obtained at baseline and on day 14.

Official Title
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Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Echinacea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients infected with HIV-1 (at least one documented positive Western-Blot). Age =/+ 18 years. Patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 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. Active alcohol consumption (> 50 g / day) or illicit drugs (except cannabis). Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: darunavir/ritonavir + root of Echinacea purpurea<br>darunavir/ritonavir + root of Echinacea purpurea | Drug: Echinacea<br>* darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours<br>* Other names: N/H;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentration of darunavir and ritonavir |  | DAY 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance (CL/F) |  | DAY 14 | 
| Volume of distribution (V/F) |  | DAY 14 | 
| Elimination half-life (t1/2) |  | DAY 14 | 
| Area under the plasma concentration-time curve during the dosing interval |  | DAY 14 | 
| Adverse events and laboratory alterations |  | DAY 14 | 
| HIV Viral load in plasma |  | DAY 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Darunavir, Echinacea purpurea, Interaction, Complementary Therapies