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Stanford Universities: The Stanford HIV Aging Cohort

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT01401348
Collaborator
(none)
154
Enrollment
1
Location
60
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    154 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Stanford HIV Aging Cohort (SHAC)
    Actual Study Start Date :
    Dec 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Dec 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. neurocognitive testing [1 year]

      Controlled oral word association test-FAS, Paced auditory serial addition task, trail making a and b, REY auditory verbal learning test, grooved peg board, timed gait

    Secondary Outcome Measures

    1. cardiovascular testing [1 yr]

      ankle-brachial index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Philip Grant, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Philip Grant, Principal Investigator, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01401348
    Other Study ID Numbers:
    • SU-12142010-7318
    First Posted:
    Jul 25, 2011
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Immunologic Deficiency Syndromes

    Study Results

    No Results Posted as of Mar 17, 2021