View Clinical Trial (Medical Research Study)
Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)
| City: |
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Omaha |
| State: |
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Nebraska |
| Zip Code: |
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68198 |
| Conditions: |
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HIV - Aging |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Diagnosed with HIV infection.
- 20-40 years of age or older than 50.
- If taking antiretroviral therapy, on stable therapy for the past 12 weeks and not
anticipated to require a change in therapy during the following 6 weeks.
- If not taking antiretroviral therapy, not anticipated to initiate therapy in the next
6 weeks.
- Ability to provide written informed consent.
- Ability to complete the questionnaires in English.
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 psychiatric illness including schizophrenia, severe depression, or severe
bipolar affective disorder that, in the opinion of the investigator, could confound
performance of or the 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.
- Any other condition that, in the opinion of the investigator, is a contraindication
to participation.
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| NCT ID: |
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NCT01186042 |
| Primary Contact: |
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Principal Investigator
Susan Swindells, MBBS
University of Nebraska
Frances G. Van Meter, APRN
Phone: 402-559-8163
Email: fvanmete@unmc.edu
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| Backup Contact: |
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Email: jloneill@unmc.edu
Jennifer L. O'Neill, RN, BSN
Phone: 402-559-4408
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| Location Contact: |
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Omaha, Nebraska 68198
United States
Frances G. Van Meter, APRN
Phone: 402-559-8163
Email: fvanmete@unmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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