Trial | NCT01046890  Report issue

Official Title

Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    echinacea ...

  • Study Participants

    15
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.
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 Started
Jan 31
2010
Primary Completion
Mar 31
2010
Study Completion
Apr 30
2010
Last Update
Dec 04
2019

Drug Echinacea

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

  • Other names: N/H

darunavir/ritonavir + root of Echinacea purpurea Experimental

darunavir/ritonavir + root of Echinacea purpurea

Criteria 

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
No Results Posted