Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00675766
First received: May 7, 2008
Last updated: September 19, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
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: 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: September 19, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014