NCT00347750

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 3, 2015

Status Verified

April 1, 2007

Enrollment Period

1 year

First QC Date

July 3, 2006

Last Update Submit

November 1, 2015

Conditions

HIV InfectionAIDS

Keywords

LopinavirPharmacokineticPharmacodynamicEthiopian populationCaucasian population

Interventions

Lopinavir pharmacokinetic/pharmacodynamic analysisDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All HIV infected Ethiopian and Non-Ethiopian subjects
  • AIDS diseased Ethiopian and Non-Ethiopian individuals

You may not qualify if:

  • Individuals who are unable to sign the informed concent
  • Individuals unable to take oral medications
  • Individuals who described Lopinavir allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Norberto Krivoy, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

November 3, 2015

Record last verified: 2007-04

Locations

IL(1)