HIV InfectionsNCT00675766
Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences
An observational study of HIV Infections, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Feb 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Year 1) and 1-year follow-up (Year 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startSep 2005
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Charles Hinkin, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675766
- Sponsor's protocol ID
- AGCG-012-04F
- Status last verified
- Apr 2015
- First submitted
- 7 May 2008
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23314403
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences
- ClinicalTrials.gov ID
- NCT00675766
- Acronym / sponsor ID
- AGCG-012-04F
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropsychological Status (i.e., Cognitive Functioning)
Time frame: Baseline (Year 1) and 1-year follow-up (Year 2)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23314403Foley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Hinkin, PhD principal investigator
VA Greater Los Angeles Healthcare System, West LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Status (i.e., Cognitive Functioning) (time frame: Baseline (Year 1) and 1-year follow-up (Year 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00675766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.