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Drug Interactions Between Silimarine and Darunavir/Ritonavir
This study has been completed.
Sponsor:
Fundacio Lluita Contra la SIDA
Collaborators:
IrsiCaixa
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier:
NCT01346982
First received: April 18, 2011
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.
| Condition | Intervention | Phase |
|---|---|---|
| HIV | Drug: Silimarine | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Drug Interactions Between Silimarine And Darunavir/Ritonavir |
Resource links provided by NLM:
Further study details as provided by Fundacio Lluita Contra la SIDA:
Primary Outcome Measures:
- Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir [ Time Frame: DAY 0, day 14 ]
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 15 |
| Study Start Date: | March 2011 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Silimarine
darunavir + ritonavir + silimarine
|
Drug: Silimarine
darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346982
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346982
Locations
| Spain | |
| Lluita contra la Sida Foundation, HIV Unit | |
| Badalona, Barcelona, Spain, 08916 | |
Sponsors and Collaborators
Fundacio Lluita Contra la SIDA
IrsiCaixa
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
| Responsible Party: | Fundacio Lluita Contra la SIDA |
| ClinicalTrials.gov Identifier: | NCT01346982 History of Changes |
| Other Study ID Numbers: |
SILIDAR 2010-021159-25 |
| Study First Received: | April 18, 2011 |
| Last Updated: | September 29, 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 |
ClinicalTrials.gov processed this record on June 27, 2017