Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Echinacea

• Registration Number: NCT01046890
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
darunavir/ritonavir + root of Echinacea purpurea	Echinacea	darunavir/ritonavir + root of Echinacea purpurea

Primary Outcome Measures

Name	Time	Method
plasma concentration of darunavir and ritonavir	DAY 14

Secondary Outcome Measures

Name	Time	Method
Volume of distribution (V/F)	DAY 14
Elimination half-life (t1/2)	DAY 14
Clearance (CL/F)	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

Trial Locations

Locations (1)

Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation; 🇪🇸 Badalona, Spain