EFV Pharmacokinetics & Pharmacogenomics in Older HIV-infected Patients

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Treatments: Efavirenz

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.