Drug Interactions Between Silimarine and Darunavir/Ritonavir

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Status and phase

Completed

Phase 4

Conditions

HIV

Treatments

Drug: Silimarine

Study type

Interventional

Funder types

Other

Identifiers

NCT01346982

SILIDAR

2010-021159-25

Details and patient eligibility

About

This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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).