N/A
N=223
Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00675766 ↗Enrolled (actual)
223
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Neuropsychological Status (i.e., Cognitive Functioning) — 0.008; .484; -.084; -.482 z-score composites of cognitive domains — p=0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neuropsychological Status (i.e., Cognitive Functioning) |
0.008; .484; -.084; -.482; -.091; .517 | 0.001 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00675766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.