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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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00347750
Enrollment
0
Registered
2006-07-04
Start date
2006-09-30
Completion date
2007-09-30
Last updated
2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV Infection

Keywords

Lopinavir, Pharmacokinetic, Pharmacodynamic, Ethiopian population, Caucasian population

Brief summary

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.

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.

Interventions

DRUGLopinavir pharmacokinetic/pharmacodynamic analysis

Sponsors

Ministry of Health, Israel
CollaboratorOTHER_GOV
Rambam Health Care Campus
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026