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Completed

NCT Number: NCT01046890

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation

Badalona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

echinacea

Drug

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

Other names: N/H

Primary outcomes

  1. plasma concentration of darunavir and ritonavir

    Time frame: DAY 14

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
  • IrsiCaixa

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 12, 2010
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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