Back to resultsDrug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Echinacea
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Darunavir, Echinacea purpurea, Interaction, Complementary Therapies
Eligibility 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
Sites / Locations
- Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
darunavir/ritonavir + root of Echinacea purpurea
Arm Description
darunavir/ritonavir + root of Echinacea purpurea
Outcomes
Primary Outcome Measures
plasma concentration of darunavir and ritonavir
Secondary Outcome Measures
Clearance (CL/F)
Volume of distribution (V/F)
Elimination half-life (t1/2)
Area under the plasma concentration-time curve during the dosing interval
Adverse events and laboratory alterations
HIV Viral load in plasma
Full Information
NCT ID
NCT01046890
First Posted
January 11, 2010
Last Updated
December 3, 2019
Sponsor
Germans Trias i Pujol Hospital
Collaborators
IrsiCaixa, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
1. Study Identification
Unique Protocol Identification Number
NCT01046890
Brief Title
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Official Title
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
IrsiCaixa, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Darunavir, Echinacea purpurea, Interaction, Complementary Therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
darunavir/ritonavir + root of Echinacea purpurea
Arm Type
Experimental
Arm Description
darunavir/ritonavir + root of Echinacea purpurea
Intervention Type
Drug
Intervention Name(s)
Echinacea
Other Intervention Name(s)
N/H
Intervention Description
darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours
Primary Outcome Measure Information:
Title
plasma concentration of darunavir and ritonavir
Time Frame
DAY 14
Secondary Outcome Measure Information:
Title
Clearance (CL/F)
Time Frame
DAY 14
Title
Volume of distribution (V/F)
Time Frame
DAY 14
Title
Elimination half-life (t1/2)
Time Frame
DAY 14
Title
Area under the plasma concentration-time curve during the dosing interval
Time Frame
DAY 14
Title
Adverse events and laboratory alterations
Time Frame
DAY 14
Title
HIV Viral load in plasma
Time Frame
DAY 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Moltó, MD,PhD
Organizational Affiliation
Lluita contra la Sida Foundation, HIV Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
City
Badalona
ZIP/Postal Code
08916
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
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