NCT01046890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

January 11, 2010

Last Update Submit

December 3, 2019

Conditions

HIV Infections

Keywords

DarunavirEchinacea purpureaInteractionComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • plasma concentration of darunavir and ritonavir

    DAY 14

Secondary Outcomes (6)

  • Clearance (CL/F)

    DAY 14

  • Volume of distribution (V/F)

    DAY 14

  • Elimination half-life (t1/2)

    DAY 14

  • Area under the plasma concentration-time curve during the dosing interval

    DAY 14

  • Adverse events and laboratory alterations

    DAY 14

  • +1 more secondary outcomes

Study Arms (1)

darunavir/ritonavir + root of Echinacea purpurea

EXPERIMENTAL

darunavir/ritonavir + root of Echinacea purpurea

Drug: Echinacea

Interventions

EchinaceaDRUG

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

Also known as: N/H
darunavir/ritonavir + root of Echinacea purpurea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.
  • Voluntary written informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Badalona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Echinacea extract

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jose Moltó, MD,PhD

    Lluita contra la Sida Foundation, HIV Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

ES(1)