Pharmacokinetics and Pharmacodynamics of an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations
This study has been withdrawn prior to enrollment.
(lack of participants)
Sponsor:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00347750
First Posted: July 4, 2006
Last Update Posted: November 3, 2015
Collaborator:
Ministry of Health, Israel
Information provided by:
Rambam Health Care Campus
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Purpose
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 | Intervention | Phase |
|---|---|---|
| HIV Infection AIDS | Drug: Lopinavir pharmacokinetic/pharmacodynamic analysis | Phase 3 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Pharmacokinetics and Pharmacodynamics of Lopinavir an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations |
Resource links provided by NLM:
Further study details as provided by Rambam Health Care Campus:
| Enrollment: | 0 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility
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 Submitted: | July 3, 2006 |
| First Posted: | July 4, 2006 |
| 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 |