Pharmacokinetics and Pharmacodynamics of an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations - Full Text View

Sponsors and Collaborators:	Rambam Health Care Campus Ministry of Health, Israel
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00347750

Purpose

The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.

Condition	Intervention	Phase
HIV Infection AIDS	Drug: Lopinavir pharmacokinetic/pharmacodynamic analysis	Phase III

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Lopinavir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Prospective Study
Official Title:	Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations

Further study details as provided by Rambam Health Care Campus:

Study Start Date:

September 2006

Detailed Description:

The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All HIV infected Ethiopian and Non-Ethiopian subjects
AIDS diseased Ethiopian and Non-Ethiopian individuals

Exclusion Criteria:

Individuals who are unable to sign the informed concent
Individuals unable to take oral medications
Individuals who described Lopinavir allergy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347750

Locations

Israel
Rambam Health Care Campus
Haifa, Israel, 31096

Sponsors and Collaborators

Rambam Health Care Campus

Ministry of Health, Israel

Investigators

Principal Investigator:

Norberto Krivoy, MD

Rambam Health Care Campus

More Information

No publications provided

Study ID Numbers:	001-2006.CTIL
Study First Received:	July 3, 2006
Last Updated:	May 16, 2007
ClinicalTrials.gov Identifier:	NCT00347750
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

Lopinavir
Pharmacokinetic
Pharmacodynamic
Ethiopian population
Caucasian population

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on February 12, 2009