NCT01186042

Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV
• Aging

Interventions

Type	Name	Description
OTHER	Observational	No intervention

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-12-17
• Completion: 2014-12-17
• First posted: 2010-08-20
• Last updated: 2023-09-06

Locations

1 site across 1 country: United States