EFV Pharmacokinetics & Pharmacogenomics in Older HIV-infected Patients

CompletedOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

December 1, 2013

Primary Completion Date

May 1, 2014

Study Completion Date

August 1, 2014

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."

Trial Locations (1)

68198

University of Nebraska Medical Center, Omaha

All Listed Sponsors
lead

University of Nebraska

OTHER

NCT01886404 - EFV Pharmacokinetics & Pharmacogenomics in Older HIV-infected Patients | Biotech Hunter | Biotech Hunter