HIVPhase 4NCT01346982
Drug Interactions Between Silimarine and Darunavir/Ritonavir
A Phase 4 study testing Silimarine in people with HIV, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
Trial summary
This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV
- What is being tested?
- Silimarine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Jul 2011
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Lluita contra la Sida Foundation, HIV Unit
Badalona, Barcelona, 08916
About this study
Official title: Drug Interactions Between Silimarine And Darunavir/Ritonavir
This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.
Read the detailed description
The silimarine is the main component of milk thistle (Sylibum marianum), a medicinal herb which, due to its attributed hepatoprotective properties, is widely used by HIV infected patients
15 patients on stable antiretroviral therapy including darunavir/ritonavir 600/100 mg twice a day during four weeks will be enrolled. After their inclusion in the study, patients will receive treatment with silimarine (150 mg every 8 hours) from day 1 until two weeks later (day 14). On days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the administration of darunavir/ritonavir, and darunavir and ritonavir concentrations in plasma will be determined by high performance liquid chromatography using a validated method.
- Conditions
- HIV
- Being tested
- Silimarine
- Keywords
- Darunavir, Silimarine, interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilimarineDrug
darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours)
| Study group | Role | What they receive |
|---|---|---|
| Silimarine | Experimental | darunavir + ritonavir + silimarine Receives: Drug: Silimarine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir
Measured: DAY 0, day 14
Secondary outcomes (6)
Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir
Measured: DAY 0, day 14
Darunavir and ritonavir clearance (CL/F)
Change from day 0 in Darunavir and ritonavir clearance at day 14
Measured: DAY 0, day 14
Darunavir and ritonavir volume of distribution (V/F)
Change from day 0 in Darunavir and ritonavir volume of distribution at day 14
Measured: DAY 0, day 14
Darunavir and ritonavir elimination half-life (t1/2) of darunavir and ritonavir
Measured: DAY 0, day 14
Darunavir and ritonavir trough concentration in plasma
Measured: DAY 0, day 14
Adverse events and laboratory abnormalities
Number of patients with adverse events and laboratory abnormalities grade 3 or 4
Measured: DAY 0, 14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- IrsiCaixa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346982
- Sponsor's protocol ID
- SILIDAR
- Other IDs
- 2010-021159-25
- Status last verified
- Sep 2011
- First submitted
- 18 Apr 2011
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interactions Between Silimarine And Darunavir/Ritonavir
- ClinicalTrials.gov ID
- NCT01346982
- Acronym / sponsor ID
- SILIDAR
- Conditions
- HIV
- Keywords
- Darunavir, Silimarine, interaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- IrsiCaixa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 May 2011 (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.
This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.
Detailed description
The silimarine is the main component of milk thistle (Sylibum marianum), a medicinal herb which, due to its attributed hepatoprotective properties, is widely used by HIV infected patients
15 patients on stable antiretroviral therapy including darunavir/ritonavir 600/100 mg twice a day during four weeks will be enrolled. After their inclusion in the study, patients will receive treatment with silimarine (150 mg every 8 hours) from day 1 until two weeks later (day 14). On days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the administration of darunavir/ritonavir, and darunavir and ritonavir concentrations in plasma will be determined by high performance liquid chromatography using a validated method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silimarine | Experimental | Drug: Silimarinedarunavir + ritonavir + silimarine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 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).
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 |
|---|---|---|
| Silimarinedarunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours) | Drug | Silimarine |
Primary outcome
Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir
Time frame: DAY 0, day 14
6 secondary outcomes
Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir
Time frame: DAY 0, day 14
Darunavir and ritonavir clearance (CL/F)
Time frame: DAY 0, day 14
Darunavir and ritonavir volume of distribution (V/F)
Time frame: DAY 0, day 14
Darunavir and ritonavir elimination half-life (t1/2) of darunavir and ritonavir
Time frame: DAY 0, day 14
Darunavir and ritonavir trough concentration in plasma
Time frame: DAY 0, day 14
Adverse events and laboratory abnormalities
Time frame: DAY 0, 14, 28
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 14 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Silimarine in people with HIV, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia 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 4 inclusion and 2 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 14 Nov 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?
Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir (time frame: DAY 0, 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 14 Nov 2019.