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

April 18, 2011
September 29, 2011
March 2011
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01346982 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
Not Provided
Not Provided
 
Drug Interactions Between Silimarine and Darunavir/Ritonavir
Drug Interactions Between Silimarine And Darunavir/Ritonavir

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

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: Silimarine
darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours)
Experimental: Silimarine
darunavir + ritonavir + silimarine
Intervention: Drug: Silimarine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2011
July 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01346982
SILIDAR, 2010-021159-25
No
Fundacio Lluita Contra la SIDA
Fundacio Lluita Contra la SIDA
  • Irsi-Caixa Laboratory
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Not Provided
Fundacio Lluita Contra la SIDA
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP