Stanford Universities: The Stanford HIV Aging Cohort



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2010
End Date:December 2016

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The Stanford HIV Aging Cohort (SHAC)

A research study to evaluate the effect of aging and HIV on neurocognitive dysfunction
(declining ability to process information), physical frailty and heart disease. HIV-infected
participants whose virus is controlled on antiretroviral medications will be studied to
determine the rates and risk factors of developing these conditions.

With advances in antiretroviral therapy, the life expectancy of HIV-infected individuals
continues to improve with older individuals representing a rapidly growing proportion of
those infected. However, despite improved life expectancy, substantial residual morbidity
remains in treated HIV including increased rates of neurocognitive dysfunction, frailty, and
cardiovascular disease. As these conditions also increase with normal aging, HIV is often
thought to be a risk factor for "early" or "accelerated" aging. Prior studies have generally
focused on HIV-specific factors and risk for neurocognitive dysfunction, frailty, and
cardiovascular disease, while few have examined extensively risk factors found to be
significant for these conditions in the general population.

The investigators hypothesize that the effects of age and HIV will be synergistic on the
rates of non-AIDS morbidity. While the correlates and risk factors for non-AIDS morbidity in
younger individuals may largely be related to HIV, in older individuals with sustained
virologic control, traditional risk factors for neurocognitive disease, frailty, and
cardiovascular disease will contribute more significantly to disease than HIV-specific risk
factors. Our primary objectives are to:

1. Define the prevalence and incidence of neurocognitive dysfunction, frailty, and
cardiovascular disease in a well-defined cohort of aging virologically suppressed
HIV-infected individuals.

2. Identify correlates and risk factors for prevalent and incident neurocognitive
dysfunction, frailty, and cardiovascular disease.

3. Compare and contrast the identified correlates and risk factors for the co-morbidities
of interest in older (>50 years old) and younger HIV-infected individuals.

Inclusion Criteria:

- Subjects must have an HIV RNA level below the limit of quantification (e.g., <75
copies, <50 copies, or <48 copies/mL, depending on the assay used) for at least 6
months excluding "blips" (e.g., a single measurement between 48-200 copies/mL
preceded and followed by measurements below the limit of quantification) while on
antiretroviral therapy.

Exclusion Criteria:

1. Completed treatment for any acute systemic infection (other than HIV-1) less than
four weeks before study entry.

2. Any active brain infection (except for HIV-1), brain neoplasm, or space-occupying
brain lesion.

3. Receipt of immunomodulating medication (e.g., corticosteroids, immunoglobulin, etc.)
within four weeks of study entry.

4. Any active psychiatric illness including schizophrenia, severe depression, or severe
bipolar affective disorder that, in the opinion of the investigator, could confound
the analysis of the neuropsychological test results.

5. Active drug or alcohol abuse that, in the investigator's opinion, could prevent
compliance with study procedures or confound the analysis of study endpoints.

6. Unable to provide informed consent
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Stanford, CA
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