Clinical trial

Efavirenz Pharmacokinetics and Pharmacogenomics in Older HIV-infected Patients

Name

0209-13-FB

Description

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.

Trial arms

Trial start

2013-12-01

Estimated PCD

2014-05-01

Trial end

2014-08-01

Status

Completed

Treatment

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.

Arms:

Efavirenz Group

Other names:

EFV, Sustiva

Size

Primary endpoint

Pharmacokinetics of EFV in older HIV-infected patients

one year

Eligibility criteria

Inclusion criteria: 1. HIV infection. 2. 50 years of age or older. 3. Ability to provide written informed consent. 4. Ability to complete the questionnaires in English, as the questionnaires have not been validated in other languages. 5. On stable efavirenz containing antiretroviral therapy for the past 12 weeks and not anticipated to require a change in therapy during the following 6 weeks. Exclusion Criteria: 1. Completion of treatment for any intercurrent acute infection less than four weeks before study entry. Maintenance or prophylactic therapy is permitted for opportunistic infections. 2. Any active, severe psychiatric illness that, in the opinion of the investigator, could confound performance of the study procedures and/or analysis of the test results. 3. Active drug or alcohol abuse that, in the investigator's opinion, could compromise compliance with study procedures or confound the analysis of the test results. 4. Major neurologic disease such as multiple sclerosis or stroke, active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion. 5. Current delirium or intoxication. 6. Pregnancy. 7. Breastfeeding. 8. Any other condition that, in the opinion of the investigator, is a contraindication to participation.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

Updated at

2023-12-12

1 organization

1 product

1 indication

Organization

University of Nebraska

Product

Efavirenz

Indication

HIV Infection