Status:
COMPLETED
EFV Pharmacokinetics & Pharmacogenomics in Older HIV-infected Patients
Lead Sponsor:
University of Nebraska
Conditions:
HIV Infection
Eligibility:
All Genders
50+ years
Brief 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...
Detailed Description
The Centers for Disease Control estimates that up to 15% of newly diagnosed cases of HIV infection are among people 50 years of age or older. By 2015, more than one-half of all HIV-infected individual...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- HIV infection.
- 50 years of age or older.
- Ability to provide written informed consent.
- Ability to complete the questionnaires in English, as the questionnaires have not been validated in other languages.
- 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:
- Completion of treatment for any intercurrent acute infection less than four weeks before study entry. Maintenance or prophylactic therapy is permitted for opportunistic infections.
- 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.
- 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.
- Major neurologic disease such as multiple sclerosis or stroke, active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
- Current delirium or intoxication.
- Pregnancy.
- Breastfeeding.
- Any other condition that, in the opinion of the investigator, is a contraindication to participation.
Exclusion
Key Trial Info
Start Date :
December 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01886404
Start Date
December 1 2013
End Date
August 1 2014
Last Update
December 12 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198