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

Rambam Health Care Campus

Status: Withdrawn

Conditions: AIDS; HIV Infection

Treatments: Drug: Lopinavir pharmacokinetic/pharmacodynamic analysis

Study type: Observational

Funder types: Other

Identifiers

NCT00347750

001-2006.CTIL

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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