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Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra

NCT00176033 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2009-02-13

No results posted yet for this study

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).

Conditions

  • Healthy
  • Pharmacokinetics

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Gerd Mikus, MD, BSc · Department of Internal Medicine VI

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00176033 on ClinicalTrials.gov