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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
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Drug: Echinacea
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • plasma concentration of darunavir and ritonavir [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046890

Locations
Spain
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Badalona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Irsi-Caixa Foundation
Investigators
Principal Investigator: Jose Moltó, MD,PhD Lluita contra la Sida Foundation, HIV Unit
  More Information

No publications provided

Responsible Party: Lluita Sida Foundation
ClinicalTrials.gov Identifier: NCT01046890     History of Changes
Other Study ID Numbers: EQUIDAR
Study First Received: January 11, 2010
Last Updated: May 4, 2010
Health Authority: Spain: Ministry of Health

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
 Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013