HIV InfectionsPhase 4NCT01046890
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
A Phase 4 study testing Echinacea in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Echinacea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Badalona, 08916
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Echinacea
- Keywords
- Darunavir, Echinacea purpurea, Interaction, Complementary Therapies
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchinaceaDrug
Also called N/H
darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| darunavir/ritonavir + root of Echinacea purpurea | Experimental | darunavir/ritonavir + root of Echinacea purpurea Receives: Drug: Echinacea |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration of darunavir and ritonavir
Measured: DAY 14
Secondary outcomes (6)
Clearance (CL/F)
Measured: DAY 14
Volume of distribution (V/F)
Measured: DAY 14
Elimination half-life (t1/2)
Measured: DAY 14
Area under the plasma concentration-time curve during the dosing interval
Measured: DAY 14
Adverse events and laboratory alterations
Measured: DAY 14
HIV Viral load in plasma
Measured: DAY 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IrsiCaixa, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
- Investigators
- Jose Moltó, MD,PhD, Principal investigator, Lluita contra la Sida Foundation, HIV Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046890
- Sponsor's protocol ID
- EQUIDAR
- Status last verified
- Dec 2019
- First submitted
- 11 Jan 2010
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
- ClinicalTrials.gov ID
- NCT01046890
- Acronym / sponsor ID
- EQUIDAR
- Conditions
- HIV Infections
- Keywords
- Darunavir, Echinacea purpurea, Interaction, Complementary Therapies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- IrsiCaixa, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| darunavir/ritonavir + root of Echinacea purpurea | Experimental | Drug: Echinaceadarunavir/ritonavir + root of Echinacea purpurea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchinaceaAlso: N/Hdarunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours | Drug | darunavir/ritonavir + root of Echinacea purpurea |
Primary outcome
plasma concentration of darunavir and ritonavir
Time frame: DAY 14
6 secondary outcomes
Clearance (CL/F)
Time frame: DAY 14
Volume of distribution (V/F)
Time frame: DAY 14
Elimination half-life (t1/2)
Time frame: DAY 14
Area under the plasma concentration-time curve during the dosing interval
Time frame: DAY 14
Adverse events and laboratory alterations
Time frame: DAY 14
HIV Viral load in plasma
Time frame: DAY 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Moltó, MD,PhD principal investigator
Lluita contra la Sida Foundation, HIV Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echinacea in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentration of darunavir and ritonavir (time frame: DAY 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.