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Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

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ClinicalTrials.gov Identifier: NCT01046890
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : May 5, 2010
Sponsor:
Collaborator:
IrsiCaixa
Information provided by:
Germans Trias i Pujol Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Echinacea Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Study Start Date : January 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: darunavir/ritonavir + root of Echinacea purpurea
darunavir/ritonavir + root of Echinacea purpurea
 Drug: Echinacea
darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours
Other Name: N/H


Outcome Measures
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Primary Outcome Measures :
  1. plasma concentration of darunavir and ritonavir [ Time Frame: DAY 14 ]

Secondary Outcome Measures :
  1. Clearance (CL/F) [ Time Frame: DAY 14 ]
  2. Volume of distribution (V/F) [ Time Frame: DAY 14 ]
  3. Elimination half-life (t1/2) [ Time Frame: DAY 14 ]
  4. Area under the plasma concentration-time curve during the dosing interval [ Time Frame: DAY 14 ]
  5. Adverse events and laboratory alterations [ Time Frame: DAY 14 ]
  6. HIV Viral load in plasma [ Time Frame: DAY 14 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046890


Locations
Spain
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Badalona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
IrsiCaixa
Investigators
Principal Investigator: Jose Moltó, MD,PhD Lluita contra la Sida Foundation, HIV Unit
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Lluita Sida Foundation
ClinicalTrials.gov Identifier: NCT01046890     History of Changes
Other Study ID Numbers: EQUIDAR
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: May 2010

Keywords provided by Germans Trias i Pujol Hospital:
Darunavir
Echinacea purpurea
Interaction
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Darunavir
 HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors