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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Lopinavir/Ritonavir on Endothelial Function

NCT00076414

Healthy

COMPLETED PHASE1

Kaletra in Combination With Antiretroviral Agents

NCT01076179

Human Immunodeficiency Virus

COMPLETED

Kaletra: Therapy With Double Protease Inhibitors

NCT01075191

Human Immunodeficiency Virus

COMPLETED

GSK706769/KALETRA Drug-drug Interaction Study

NCT00723775

Infection, Human Immunodeficiency Virus

COMPLETED PHASE1

High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease

NCT00247143

HIV AIDS

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective:

Measurement of AUC, Cmax, tmax, t1/2 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Pharmacokinetics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Good state of health

Exclusion Criteria

* Drug treatment with known inhibitors or inducers of cytochrome P450 isozymes or ABC-transporters within the preceding 2 months
* Any acute or chronic illness
* Smoking
* Pregnancy
* Alcohol or drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes