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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00347750
Recruitment Status : Withdrawn (lack of participants)
First Posted : July 4, 2006
Last Update Posted : November 3, 2015
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infection AIDS Drug: Lopinavir pharmacokinetic/pharmacodynamic analysis Phase 3

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.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations
Study Start Date : September 2006
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lopinavir
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00347750     History of Changes
Other Study ID Numbers: 001-2006.CTIL
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: April 2007

Keywords provided by Rambam Health Care Campus:
Lopinavir
Pharmacokinetic
Pharmacodynamic
Ethiopian population
Caucasian population

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lopinavir
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors