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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This study has been withdrawn prior to enrollment.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

July 3, 2006
May 16, 2007
September 2006
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Complete list of historical versions of study NCT00347750 on ClinicalTrials.gov Archive Site
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Pharmacokinetics and Pharmacodynamics of an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations
Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • HIV Infection
  • AIDS
Drug: Lopinavir pharmacokinetic/pharmacodynamic analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00347750
001-2006.CTIL
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Rambam Health Care Campus
Ministry of Health, Israel
Principal Investigator: Norberto Krivoy, MD Rambam Health Care Campus
Rambam Health Care Campus
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP