Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences - Full Text View

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

MedlinePlus related topics:

AIDS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Neuropsychological Status [ Time Frame: Annually ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	September 2005
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts

1

HIV-positive adults 50 and older/ HIV-positive adults 18-40 yeard 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

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675766

Contacts


Contact: Marta B Robinet	(310) 268-3680	mstefani@ucla.edu

Contact: Charles Hinkin, PhD		charles.hinkin@va.gov

Locations


United States, California
	VA Greater Los Angeles Healthcare System, West LA	Recruiting
	West Los Angeles, California, United States, 90073
	Contact: Charles Hinkin, PhD charles.hinkin@va.gov
	Contact: Marta B Robinet (310) 268-3680 mstefani@ucla.edu
	Principal Investigator: Charles Hinkin, PhD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Charles Hinkin, PhD	VA Greater Los Angeles Healthcare System, West LA

More Information

Responsible Party:	Department of Veterans Affairs ( Hinkin, Charles - Principal Investigator )
Study ID Numbers:	AGCG-012-04F
First Received:	May 7, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00675766
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00675766