NCT01346982

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 hiv

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 14, 2019

Status Verified

September 1, 2011

Enrollment Period

4 months

First QC Date

April 18, 2011

Last Update Submit

November 11, 2019

Conditions

HIV

Keywords

DarunavirSilimarineinteraction

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir

    DAY 0, day 14

Secondary Outcomes (6)

  • Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir

    DAY 0, day 14

  • Darunavir and ritonavir clearance (CL/F)

    DAY 0, day 14

  • Darunavir and ritonavir volume of distribution (V/F)

    DAY 0, day 14

  • Darunavir and ritonavir elimination half-life (t1/2) of darunavir and ritonavir

    DAY 0, day 14

  • Darunavir and ritonavir trough concentration in plasma

    DAY 0, day 14

  • +1 more secondary outcomes

Study Arms (1)

Silimarine

EXPERIMENTAL

darunavir + ritonavir + silimarine

Drug: Silimarine

Interventions

SilimarineDRUG

darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours)

Silimarine

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lluita contra la Sida Foundation, HIV Unit

Badalona, Barcelona, 08916, Spain

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2011

First Posted

May 4, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 14, 2019

Record last verified: 2011-09

Locations

ES(1)