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NCT00347750 Clinical Trial

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

HIV Infection Clinical Trial

Official title:
Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00347750
Other study ID # 001-2006.CTIL
Secondary ID
Status Withdrawn
Phase Phase 3
First received July 3, 2006
Last updated November 1, 2015
Start date September 2006
Est. completion date September 2007

Study information
Verified date April 2007
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Lopinavir pharmacokinetic/pharmacodynamic analysis

Locations
Country Name City State
Israel Rambam Health Care Campus Haifa

Sponsors (2)
Lead Sponsor Collaborator
Rambam Health Care Campus Ministry of Health, Israel

Country where clinical trial is conducted

Israel, 

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