Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

HIV Infections Clinical Trial

Official title:

Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046890
• Other study ID #: EQUIDAR
• Status: Completed
• Phase: Phase 4
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: December 2019
• Source: Germans Trias i Pujol Hospital
• 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 widely used by HIV infected patients: Echinacea sp. and the protease inhibitor darunavir/ritonavir.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Echinacea
darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours

Locations

Country	Name	City	State
Spain	Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation	Badalona

Sponsors (3)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundacio Lluita Contra la SIDA, IrsiCaixa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentration of darunavir and ritonavir		DAY 14
Secondary	Clearance (CL/F)		DAY 14
Secondary	Volume of distribution (V/F)		DAY 14
Secondary	Elimination half-life (t1/2)		DAY 14
Secondary	Area under the plasma concentration-time curve during the dosing interval		DAY 14
Secondary	Adverse events and laboratory alterations		DAY 14
Secondary	HIV Viral load in plasma		DAY 14