Stanford Universities: The Stanford HIV Aging Cohort - Full Text View

Purpose

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
Acquired Immunodeficiency Syndrome


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Stanford HIV Aging Cohort (SHAC)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

neurocognitive testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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:

cardiovascular testing [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
ankle-brachial index

Biospecimen Retention: Samples Without DNA

PBMC's


Estimated Enrollment:	300
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

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:

Define the prevalence and incidence of neurocognitive dysfunction, frailty, and cardiovascular disease in a well-defined cohort of aging virologically suppressed HIV-infected individuals.
Identify correlates and risk factors for prevalent and incident neurocognitive dysfunction, frailty, and cardiovascular disease.
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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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:

Completed treatment for any acute systemic infection (other than HIV-1) less than four weeks before study entry.
Any active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
Receipt of immunomodulating medication (e.g., corticosteroids, immunoglobulin, etc.) within four weeks of study entry.
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.
Active drug or alcohol abuse that, in the investigator's opinion, could prevent compliance with study procedures or confound the analysis of study endpoints.
Unable to provide informed consent

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Philip Grant, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier:	NCT01401348 History of Changes
Other Study ID Numbers:	SU-12142010-7318
Study First Received:	July 19, 2011
Last Updated:	July 15, 2015
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016