Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences
US Department of Veterans Affairs
Information provided by (Responsible Party)
VA Office of Research and Development
First received: May 7, 2008
Last updated: April 29, 2015
Last Verified: April 2015
History of Changes
While the numbers of HIV infected veterans under the age of 50 are declining, the percentage
of HIV infected veterans over the age of 50 is increasing with the largest percentage
increases in the 50-59 age group and the 70+ age group. With increasing incidence rates of
new cases among individuals over 50 years of age and the longer life expectancies of the
current HIV-infected population, it becomes increasingly important to better understand the
impact of the aging process on the clinical and behavioral manifestations of HIV/AIDS.
The project seeks to determine the effect of age on neuropsychological performance in HIV+ persons. This objective seeks to determine the degree to which older age represents an independent risk factor for neuropsychological impairment in HIV infected persons, with a particular emphasis on those cognitive processes that are preferentially impacted by both the normal aging process as well as HIV infection. Additionally, another aim of the study is to determine the impact of neuropsychological decline on everyday functional abilities among older vs. younger HIV+ adults. This objective seeks to determine the effects of advancing age and neuropsychological impairment on the ability of HIV+ persons to discharge more demanding requirements of independent living (e.g., driving, financial management, medication adherence). The project will last for a duration of 5 years.
Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences|
Further study details as provided by VA Office of Research and Development:
Primary Outcome Measures
Neuropsychological Status (i.e., Cognitive Functioning)
[ Time Frame: Baseline (Year 1) and 1-year follow-up (Year 2) ]
Neurocognitive functions refer to cognitive abilities, namely learning/memory, motor speed, psychomotor speed, language, attention, visuospatial abilities, & executive function. They are measured using standard clinical neuropsychological test battery that included: HVLT, BVMT-R, Trails A & B, WCST-64, WAIS-Symbol Search/Digit Coding/Letter-Number Sequencing/Block Design, FAS, & Animals. Subgroups of these tasks were combined to create composite scores indicating participants' score on each cognitive domains. To make these cognitive domain composite scores, each participant's raw score on each of these tests was converted into a within-sample standardized score (i.e., z-score), which are normally distributed with a mean of 0 & SD of 1. Then, these standardized scores were summed to create composite scores for each cognitive domain and then averaged to create a global neuropsychological function composite score. A positive composite score represents a better outcome for all variables.
|Study Start Date:||September 2005|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
HIV-positive adults 50 and older/ HIV-positive adults 18-40 years old
HIV-negative controls 50 and older / HIV-negative controls 18-40 years old
HIV-negative controls 50 and older / HIV-negative controls 18-40 years old
HIV-negative controls 18-40 years old
Over the past several years the HIV epidemic has changed from a disease primarily of younger,
gay/bisexual, Caucasian men to one increasingly affecting people of color, women, and, of
specific relevance to this application, the older adult. Indeed, the number of AIDS cases in
individuals over the age of 50 has more than tripled over the last several years, with the
CDC now estimating that in the United States 15% of all patients with AIDS are over age 50.1
There is reason to believe that the incidence, clinical manifestations and course of
HIV-associated CNS dysfunction may differ as a function of age. Since the mid 1980's VA has
been at the vanguard of institutions engaged in research and clinical care of HIV-infected
adults. With specific regard to the issue of aging and HIV, HIV-infected veterans have tended
to be significantly older than patients drawn from the general community. For example, at the
West Los Angeles VA 303 of the 583 (52%) HIV-infected patients being followed by the
Infectious Disease clinic are over the age of 50. Across the entire VA system, there are
nearly twice as many HIV infected veterans over the age of 70 than under 30 years of age. 2
Yet, the vast majority of research conducted to date has been on younger adults - the degree
to which such data will generalize to the older veteran population is unclear. Also unclear
is whether advancing age confers an independent risk for cognitive impairment in HIV-infected
persons. Additionally, the functional impact (i.e., impact on daily functioning such as
driving ability, financial management, or medication adherence) of cognitive impairment in
this group remains unknown. Exploratory studies performed in the applicants' laboratory have
provided preliminary support for the hypothesis that advancing age will potentiate the
deleterious neurocognitive effects of HIV infection. Given the "graying" of the HIV epidemic,
particularly among the veteran population, research examining neurocognition among older
HIV-infected veterans as well as the functional "real world" impact of such deficits is of
great relevance to the VA mission. The results from this study could provide important
insights into interactions of age and HIV disease, and will identify targets for intervention
in advance of the burgeoning population of older infected persons.
SPECIFIC OBJECTIVES AND HYPOTHESES
Objective 1. To Determine the Effect of Age on Neuropsychological Performance in HIV+ Persons This objective seeks to determine the degree to which older age represents an independent risk factor for neuropsychological impairment in HIV infected persons, with a particular emphasis on those cognitive processes that are preferentially impacted by both the normal aging process as well as HIV infection.
Hypothesis 1.1 Controlling for potential confounding factors such as substance use and length of infection, there will be an interaction between effects of age and HIV serostatus on neuropsychological performance, and this will be evident both cross-sectionally and longitudinally. Specifically, we expect to find that older HIV+ individuals will exhibit greater rates of neuropsychological impairment (using age-corrected test norms) than younger HIV+ persons. Neurocognitive functions subserved by frontal-subcortical systems that are sensitive to the effects of both aging and HIV infection (learning, motor and psychomotor speed, executive function) will be disproportionately affected among the older HIV+ participants. While the synergistic effects of HIV and age will be evident on a cross sectional basis, they will be most pronounced when examined longitudinally over the course of the study.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
Study PopulationTo be enrolled in the study, participants must be between the ages of 18-40 years (younger groups) or 50 years old and older (older groups). The study population will consist of an ethnically diverse sample of approximately 1/3 Caucasian, 1/3 African American and 1/3 Hispanic. Approximately, 25% of participants will be female. The population will consist of veterans with additional recruitment from the community in order to meet project goals.
- To be enrolled in the study, participants must be between the ages of 18-40 years (younger groups) or > 50 years (older groups); our goal is to recruit at least 50% of older HIV+ participants who are > 60 years old.
- Eligible participants must have documented presence or absence of HIV infection (depending on their group assignment), based on serologic testing for HIV antibody (screening ELISA, confirmed by Western blot if positive).
- The documentation of HIV status will be obtained once informed consent has been established.
- CNS infection other than HIV (no opportunistic CNS disease)
- CNS neoplasm, neurosyphilis
- traumatic brain injury with loss of consciousness greater than 30 minutes
- current diagnosis of seizure disorder, current psychotic spectrum disorders (e.g., schizophrenia, bipolar disorder)
- history of drug or alcohol abuse or dependence within the past year.
Contacts and LocationsChoosing 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: NCT00675766
Locations Show More
|United States, California|
|VA Greater Los Angeles Healthcare System, West LA|
|West Los Angeles, California, United States, 90073|
Sponsors and CollaboratorsUS Department of Veterans Affairs
|Principal Investigator:||Charles Hinkin, PhD||VA Greater Los Angeles Healthcare System, West LA|
|Responsible Party:||US Department of Veterans Affairs|
|ClinicalTrials.gov Identifier:||NCT00675766 History of Changes|
|Other Study ID Numbers:||AGCG-012-04F|
|Study First Received:||May 7, 2008|
|Last Updated:||April 29, 2015|
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on May 28, 2020
This information is provided by ClinicalTrials.gov.