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

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 3


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Lopinavir

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:


Enrollment:	0
Study Start Date:	September 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00347750 History of Changes
Other Study ID Numbers:	001-2006.CTIL
Study First Received:	July 3, 2006
Last Updated:	November 1, 2015
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:


Lopinavir Pharmacokinetic Pharmacodynamic Ethiopian population Caucasian population

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Anti-HIV Agents	Lopinavir Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016