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View Clinical Trial (Medical Research Study)
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Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences - NCT00675766-90073 (Clinical Trial 219637)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy219637.aspx
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| City: |
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West Los Angeles |
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State:
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CA |
| Zip Code: |
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90073 |
| Conditions: |
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HIV Infections |
| Purpose: |
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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.
Subjects will be followed for 4 years, those who are enrolled in Year 1 will complete the
study in Year 4 whereas those who enter in Year 2 will complete the study in Year 5.
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| Study summary: |
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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.
Objective 2. 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).
Hypothesis 2.1 In both older and younger HIV+ persons, neuropsychological impairment will
be strongly associated with increased impairment on measures of daily functioning. However,
significant age by neuropsychological impairment interaction effects also are expected,
indicating greater functional impact of neuropsychological impairment in the older HIV+
group. Although comorbid medical disabilities, depression, and drug/alcohol use also will
have adverse effects on everyday functioning, the effects of neuropsychological impairment
will remain significant even after controlling for these risk factors. While the synergistic
effects of HIV and age will be evident on a cross sectional basis, they will be most
pronounced when examined longitudinally.
Hypothesis 2.2 As a group, older HIV+ participants will demonstrate better medication
adherence than will younger participants. However, older HIV+ participants who demonstrate
neuropsychological impairment will evidence significantly worse adherence than all other
HIV+ subgroups (older unimpaired, younger impaired, younger unimpaired). While adherence
rates will drop for all participants over time, the steepest decline will be seen among
neuropsychologically impaired older HIV+ participants. |
| Criteria: |
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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. |
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| Study is available at: |
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VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, CA 90073
United States
Primary Contact:
Gabriel Waterman, BA
Email: Gabriel.Waterman@va.gov
Phone: 310-268-3680
Secondary Contact:
Gabriel Waterman, BA
Email: Gabriel.Waterman@va.gov
Phone: (310) 268-3680 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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