Drug Interactions Between Silimarine and Darunavir/Ritonavir

This study has been completed.

Sponsor:

Collaborators:

Irsi-Caixa Laboratory

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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 18, 2011
Last Updated Date	September 29, 2011
Start Date ^ICMJE	March 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 3, 2011)	Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01346982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 9, 2011)	Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ] Darunavir and ritonavir clearance (CL/F) [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Darunavir and ritonavir trough concentration in plasma [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ] Adverse events and laboratory abnormalities [ Time Frame: DAY 0, 14, 28 ] [ Designated as safety issue: Yes ] Number of patients with adverse events and laboratory abnormalities grade 3 or 4
Original Secondary Outcome Measures ^ICMJE (submitted: May 3, 2011)	Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ] Darunavir and ritonavir clearance (CL/F) [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ] Darunavir and ritonavir volume of distribution (V/F) [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ] Darunavir and ritonavir elimination half-life (t1/2) of darunavir and ritonavir [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ] Darunavir and ritonavir trough concentration in plasma [ Time Frame: DAY 0, day 14 ] [ Designated as safety issue: No ] Adverse events and laboratory abnormalities [ Time Frame: DAY 0, 14, 28 ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Drug Interactions Between Silimarine and Darunavir/Ritonavir
Official Title ^ICMJE	Drug Interactions Between Silimarine And Darunavir/Ritonavir
Brief Summary	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 Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	HIV
Intervention ^ICMJE	Drug: Silimarine darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours)
Study Arm (s)	Experimental: Silimarine darunavir + ritonavir + silimarine Intervention: Drug: Silimarine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	15
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01346982
Other Study ID Numbers ^ICMJE	SILIDAR, 2010-021159-25
Has Data Monitoring Committee	No
Responsible Party	Fundacio Lluita Contra la SIDA
Study Sponsor ^ICMJE	Fundacio Lluita Contra la SIDA
Collaborators ^ICMJE	Irsi-Caixa Laboratory Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators ^ICMJE	Not Provided
Information Provided By	Fundacio Lluita Contra la SIDA
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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