An observational study in HIV and Aging, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by University of Nebraska · Observational
The purpose of this study is to find the best tests to use to investigate the differences between older and younger people with HIV disease. Test to be included will measures of memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.
Advances in the treatment of chronic HIV disease over the last 20 years have resulted in dramatic declines in morbidity and mortality. However, emerging data suggest that chronically infected patients may be aging prematurely, and/or experience increased incidence of age-related conditions. These phenomena are poorly understood. The overall goal of the CHAIN project is to support the expansion of innovative research on the effects of chronic HIV infection, co-morbidities, and aging on the central nervous system (CNS). We propose the initiation of a clinical portion to better understand the nature of the aging process in HIV-infected patients, with an emphasis on brain disease. This is a pilot, feasibility study to inform the design of a larger, prospective cohort study.
We plan to enroll 20 older HIV-infected patients (more than 50 years old) and 20 younger controls (20-40 years old), matched for gender and race/ethnicity. Participants will undergo a series of tests, at one comprehensive assessment. Demographic and medical history data will be abstracted from the medical record. Each participant will undergo a medical history and physical examination, and a battery of tests designed to evaluate neuropsychological function, activity, sleep patterns, frailty, emotional well-being and sexual health. These will consist of self-administered questionnaires and neuropsychological tests, as detailed in the Methods section. Innovative measures will be included such as an activity monitor worn by participants, and a Wii balance board to assess standing balance. Participants will be asked to keep a diary and wear the activity monitoring device for one month. Plasma and serum samples will be collected on one occasion for future testing of potential biomarkers.
2,646 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 318 observational studies indexed under Motor Activity.
Browse Motor Activity studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
University of Nebraska Medical Center HIV Clinic
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Exclusion Criteria:
20-40 years of age or older than 50
Other: Observational
No intervention
Evaluate the feasibility of enrolling older HIV-infected patients and younger controls into a prospective, observational study.
Evaluate the feasibility of enrolling older HIV-infected patients and youger controls into a prospective, observational study.
Time frame: One month
Selection of the optimal test battery to measure the areas of interest
Secondary objective includes: Selection of the optimal test battery to measure the areas of interest;
Time frame: One month
Participant acceptance of the measures involved
Secondary objective includes: Participant acceptance of the measures involved;
Time frame: One month
Preliminary data collection to inform the size and design of a larger, follow-up study.
Secondary objective includes: Preliminary data collection to inform the size and design of a larger, follow-up study.
Time frame: One month
Ran from Aug 2010 to primary completion in Dec 2014, 52 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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