Drug Interactions Between Silimarine and Darunavir/Ritonavir
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ClinicalTrials.gov Identifier: NCT01346982 |
Recruitment Status
:
Completed
First Posted
: May 4, 2011
Last Update Posted
: September 30, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Silimarine | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Drug Interactions Between Silimarine And Darunavir/Ritonavir |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: Silimarine
darunavir + ritonavir + silimarine
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Drug: Silimarine
darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours)
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- Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir [ Time Frame: DAY 0, day 14 ]
- 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 ]Change from day 0 in Darunavir and ritonavir clearance at day 14
- Darunavir and ritonavir volume of distribution (V/F) [ Time Frame: DAY 0, day 14 ]Change from day 0 in Darunavir and ritonavir volume of distribution at 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 ]Number of patients with adverse events and laboratory abnormalities grade 3 or 4

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346982
Spain | |
Lluita contra la Sida Foundation, HIV Unit | |
Badalona, Barcelona, Spain, 08916 |
Responsible Party: | Fundacio Lluita Contra la SIDA |
ClinicalTrials.gov Identifier: | NCT01346982 History of Changes |
Other Study ID Numbers: |
SILIDAR 2010-021159-25 |
First Posted: | May 4, 2011 Key Record Dates |
Last Update Posted: | September 30, 2011 |
Last Verified: | September 2011 |
Keywords provided by Fundacio Lluita Contra la SIDA:
Darunavir Silimarine interaction |
Additional relevant MeSH terms:
Ritonavir Darunavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |