Drug Interactions Between Silimarine and Darunavir/Ritonavir

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; IrsiCaixa
• Treatments: Darunavir; Ritonavir

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).