Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176033
Status:
COMPLETED
Last Update Posted:
2009-02-13
First Post:
2005-09-12
Brief Title:
Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra LopinavirRitonavir and on the Concentration Relations Between Plasma Blood Cells Saliva and Urine
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to determine the pharmacokinetics of Kaletra HIV protease inhibitors lopinavir and ritonavir in different body compartments and to assess the role of four different drug transporters MDR MRP1 MRP2 and BCRP in the tissue distribution of the two protease inhibitors The latter will be studied by comparing intracellular concentrations of peripheral blood mononuclear cells PBMCs with total and free plasma concentrations in healthy individuals These effects will be studied after single dose day 1 during steady state day 3 and during chronic treatment day 14
Detailed Description:
Objective
Measurement of AUC Cmax tmax t12 and clearance Cl of the protease inhibitor Kaletra lopinavir and ritonavir each in the plasma of healthy individuals
establish free and total plasma - blood cell concentration-relationship
establish free and total plasma - saliva concentration-relationship
establish blood cell concentration - drug transporter expression-relationship
Measurement of AUC Cmax tmax t12 and clearance Cl of the protease inhibitor Kaletra lopinavir and ritonavir each in the plasma of healthy individuals
establish free and total plasma - blood cell concentration-relationship
establish free and total plasma - saliva concentration-relationship
establish blood cell concentration - drug transporter expression-relationship
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None