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EFV Pharmacokinetics & Pharmacogenomics in Older HIV-infected Patients

NCT01886404 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-12-12

No results posted yet for this study

Summary

The primary purpose of this study is to investigate the steady-state pharmacokinetics of efavirenz in older HIV-infected patients as compared to historical controls; to investigate the relationship of drug exposure to neuropsychiatric side effects and neuropsychological performance; and to explore the role of host polymorphisms in drug metabolism in the older patient.

Conditions

  • HIV Infection

Interventions

DRUG

Efavirenz

HIV-infected subjects currently receiving efavirenz (EFV) containing antiretroviral therapy (ART) will be asked to provide plasma samples. In addition to blood samples for determination of EFV concentrations, we will collect whole blood samples for functional Single Nucleotide Polymorphism (SNP) discovery within known candidate genes of interest in drug metabolism and transport. Subjects will be at steady state for efavirenz when blood samples are collected. EFV is usually taken during the evening hours. The study consists of 2 blood draws at 12 and 18 hours post EFV dose. At the first blood draw, venous blood will be obtained by venous puncture for plasma concentrations of EFV and pharmacogenetics. At 18 hours post EFV dose , a second blood draw by venous puncture will be obtained for EFV plasma concentrations. Demographics and clinical parameters will be collected at the time of the first visit, Neuropsychological tests and questionnaires completed as well.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Uriel S Sandkovsky, MD · University of Nebraska

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-01
Primary Completion
2014-05-01
Completion
2014-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01886404 on ClinicalTrials.gov