NCT00675766|CompletedResultsDMC
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Sponsor study identifier
observational
223
1 country
1
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
May 7, 2008
Actual (reported)May 12, 2008
Actual (reported)February 2011
Actual (reported)February 2011
Actual (reported)May 4, 2015
Actual (reported)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)
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
To 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.
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073, United States
Foley JM, Gooding AL, Thames AD, Ettenhofer ML, Kim MS, Castellon SA, Marcotte TD, Sadek JR, Heaton RK, van Gorp WG, Hinkin CH. Visuospatial and Attentional Abilities Predict Driving Simulator Performance Among Older HIV-infected Adults. Am J Alzheimers Dis Other Demen. 2013 Mar;28(2):185-94. doi: 10.1177/1533317512473192. Epub 2013 Jan 11.
Large number of subjects who were lost to follow up (i.e moved from community, did not answer follow up calls to schedule visits) resulted in a reduced sample size of subjects who completed the study.
Charles Hinkin, PhD
VA Greater Los Angeles Healthcare System, West LA
223 participants (actual enrollment reported by the registry).
First Submitted
May 7, 2008
First Posted
May 12, 2008
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
HIV Prevention Intervention for People Living With HIV/AIDS
Contact the study team to confirm eligibility.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)Last Updated
May 4, 2015
Results First Posted
May 4, 2015
Record last verified: 2015-04
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