Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences

NCT00675766 | Completed Results DMC

• 1 other identifier: AGCG-012-04F
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (4)

Group 1

HIV-positive adults 50 and older/ HIV-positive adults 18-40 years old

Group 2

HIV-negative controls 50 and older / HIV-negative controls 18-40 years old

Group 3

HIV-negative controls 50 and older / HIV-negative controls 18-40 years old

Group 4

HIV-negative controls 18-40 years old

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

Related Publications (1)

• 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.

  PMID: 23314403 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Charles Hinkin
• Organization: West Los Angeles Veterans Association

chinkin@ucla.edu

310-478-3711

Study Officials

• Charles Hinkin, PhD

  VA Greater Los Angeles Healthcare System, West LA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 12, 2008
• Study Start: September 1, 2005
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 4, 2015
• Results First Posted: May 4, 2015

Record last verified: 2015-04

Locations

US (1)