Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences
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Purpose
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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences |
- Neuropsychological Status [ Time Frame: Annually ] [ Designated as safety issue: No ]
| Enrollment: | 223 |
| Study Start Date: | September 2005 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
HIV-positive adults 50 and older/ HIV-positive adults 18-40 years old
|
|
2
HIV-negative controls 50 and older / HIV-negative controls 18-40 years old
|
|
3
HIV-negative controls 50 and older / HIV-negative controls 18-40 years old
|
|
4
HIV-negative controls 18-40 years old
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| United States, California | |
| VA Greater Los Angeles Healthcare System, West LA | |
| West Los Angeles, California, United States, 90073 | |
| Principal Investigator: | Charles Hinkin, PhD | VA Greater Los Angeles Healthcare System, West LA |
More Information
No publications provided by Department of Veterans Affairs
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hinkin, Charles - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00675766 History of Changes |
| Other Study ID Numbers: | AGCG-012-04F |
| Study First Received: | May 7, 2008 |
| Last Updated: | May 11, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013