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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00347750
First received: July 3, 2006
Last updated: May 16, 2007
Last verified: April 2007
  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: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations

Resource links provided by NLM:


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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00347750     History of Changes
Other Study ID Numbers: 001-2006.CTIL
Study First Received: July 3, 2006
Last Updated: May 16, 2007
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-HIV Agents
Lopinavir
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014