HIV Infections Clinical Trial
Official title:
Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences
Verified date | April 2015 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 223 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neuropsychological Status (i.e., Cognitive Functioning) | 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. | Baseline (Year 1) and 1-year follow-up (Year 2) | No |
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