Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

This study has been completed.
Sponsor:
Collaborator:
Irsi-Caixa Foundation
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT01046890
First received: January 11, 2010
Last updated: May 4, 2010
Last verified: May 2010

January 11, 2010
May 4, 2010
January 2010
March 2010   (final data collection date for primary outcome measure)
plasma concentration of darunavir and ritonavir [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01046890 on ClinicalTrials.gov Archive Site
  • Clearance (CL/F) [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
  • Volume of distribution (V/F) [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
  • Elimination half-life (t1/2) [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve during the dosing interval [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
  • Adverse events and laboratory alterations [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
  • HIV Viral load in plasma [ Time Frame: DAY 14 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Echinacea
darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours
Other Name: N/H
Experimental: darunavir/ritonavir + root of Echinacea purpurea
darunavir/ritonavir + root of Echinacea purpurea
Intervention: Drug: Echinacea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
April 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01046890
EQUIDAR
No
Lluita Sida Foundation
Germans Trias i Pujol Hospital
Irsi-Caixa Foundation
Principal Investigator: Jose Moltó, MD,PhD Lluita contra la Sida Foundation, HIV Unit
Germans Trias i Pujol Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP