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Stanford Universities: The Stanford HIV Aging Cohort

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ClinicalTrials.gov Identifier: NCT01401348
Recruitment Status : Unknown
Verified July 2015 by Philip Grant, Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2011
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
Philip Grant, Stanford University

Study Description
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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
Acquired Immunodeficiency Syndrome

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
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Stanford HIV Aging Cohort (SHAC)
Study Start Date : December 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. neurocognitive testing [ Time Frame: 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 [ Time Frame: 1 yr ]
    ankle-brachial index


Biospecimen Retention:   Samples Without DNA
PBMC's

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 HIV-infected participants whose virus is controlled on antiretroviral medications from the Stanford Positive Care Clinic. Five (150) patients over 50 years old and five (150) patients less than 50 years old
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401348


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Philip Grant Stanford University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Philip Grant, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01401348     History of Changes
Other Study ID Numbers: SU-12142010-7318
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
 RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases