Clinical trial NCT01346982: Drug Interactions Between Silimarine and Darunavir/Ritonavir
Official title: Drug Interactions Between Silimarine And Darunavir/Ritonavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: Darunavir
Silimarine
interaction
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
Collaborators: name: IrsiCaixa
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2011-05-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir
timeFrame: DAY 0, day 14
Secondary outcomes:
measure: Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir
timeFrame: DAY 0, day 14
measure: Darunavir and ritonavir clearance (CL/F)
timeFrame: DAY 0, day 14
measure: Darunavir and ritonavir volume of distribution (V/F)
timeFrame: DAY 0, day 14
measure: Darunavir and ritonavir elimination half-life (t1/2) of darunavir and ritonavir
timeFrame: DAY 0, day 14
measure: Darunavir and ritonavir trough concentration in plasma
timeFrame: DAY 0, day 14
measure: Adverse events and laboratory abnormalities
timeFrame: DAY 0, 14, 28
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Lluita contra la Sida Foundation, HIV Unit
state: Barcelona
Study officials:
References: