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Chronic HIV Infection and Aging in NeuroAIDS (CHAIN) (CHAIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186042
First Posted: August 20, 2010
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Swindells, MBBS, University of Nebraska
July 22, 2010
August 20, 2010
September 11, 2017
August 2010
December 17, 2014   (Final data collection date for primary outcome measure)
Evaluate the feasibility of enrolling older HIV-infected patients and younger controls into a prospective, observational study. [ Time Frame: One month ]
Evaluate the feasibility of enrolling older HIV-infected patients and youger controls into a prospective, observational study.
Same as current
Complete list of historical versions of study NCT01186042 on ClinicalTrials.gov Archive Site
  • Selection of the optimal test battery to measure the areas of interest [ Time Frame: One month ]

    Secondary objective includes:

    Selection of the optimal test battery to measure the areas of interest;

  • Participant acceptance of the measures involved [ Time Frame: One month ]

    Secondary objective includes:

    Participant acceptance of the measures involved;

  • Preliminary data collection to inform the size and design of a larger, follow-up study. [ Time Frame: One month ]

    Secondary objective includes:

    Preliminary data collection to inform the size and design of a larger, follow-up study.

Same as current
Not Provided
Not Provided
 
Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)
Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)
The purpose of this study is to find the best tests to use to investigate the differences between older and younger people with HIV disease. Test to be included will measures of memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.

Advances in the treatment of chronic HIV disease over the last 20 years have resulted in dramatic declines in morbidity and mortality. However, emerging data suggest that chronically infected patients may be aging prematurely, and/or experience increased incidence of age-related conditions. These phenomena are poorly understood. The overall goal of the CHAIN project is to support the expansion of innovative research on the effects of chronic HIV infection, co-morbidities, and aging on the central nervous system (CNS). We propose the initiation of a clinical portion to better understand the nature of the aging process in HIV-infected patients, with an emphasis on brain disease. This is a pilot, feasibility study to inform the design of a larger, prospective cohort study.

We plan to enroll 20 older HIV-infected patients (more than 50 years old) and 20 younger controls (20-40 years old), matched for gender and race/ethnicity. Participants will undergo a series of tests, at one comprehensive assessment. Demographic and medical history data will be abstracted from the medical record. Each participant will undergo a medical history and physical examination, and a battery of tests designed to evaluate neuropsychological function, activity, sleep patterns, frailty, emotional well-being and sexual health. These will consist of self-administered questionnaires and neuropsychological tests, as detailed in the Methods section. Innovative measures will be included such as an activity monitor worn by participants, and a Wii balance board to assess standing balance. Participants will be asked to keep a diary and wear the activity monitoring device for one month. Plasma and serum samples will be collected on one occasion for future testing of potential biomarkers.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:
plasma
Non-Probability Sample
University of Nebraska Medical Center HIV Clinic
  • HIV
  • Aging
Other: Observational
No intervention
Aging in HIV
20-40 years of age or older than 50
Intervention: Other: Observational
Valcour V, Shikuma C, Shiramizu B, Watters M, Poff P, Selnes O, Holck P, Grove J, Sacktor N. Higher frequency of dementia in older HIV-1 individuals: the Hawaii Aging with HIV-1 Cohort. Neurology. 2004 Sep 14;63(5):822-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 17, 2014
December 17, 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with HIV infection.
  • 20-40 years of age or older than 50.
  • If taking antiretroviral therapy, on stable therapy for the past 12 weeks and not anticipated to require a change in therapy during the following 6 weeks.
  • If not taking antiretroviral therapy, not anticipated to initiate therapy in the next 6 weeks.
  • Ability to provide written informed consent.
  • Ability to complete the questionnaires in English.

Exclusion Criteria:

  • Completion of treatment for any intercurrent acute infection less than four weeks before study entry. Maintenance or prophylactic therapy is permitted for opportunistic infections.
  • Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound performance of or the analysis of the test results.
  • Active drug or alcohol abuse that, in the investigator's opinion, could compromise compliance with study procedures or confound the analysis of the test results.
  • Major neurologic disease such as multiple sclerosis or stroke, active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
  • Current delirium or intoxication.
  • Pregnancy.
  • Any other condition that, in the opinion of the investigator, is a contraindication to participation.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01186042
396-10-FB
P30MH062261 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Susan Swindells, MBBS, University of Nebraska
University of Nebraska
National Institute of Mental Health (NIMH)
Principal Investigator: Susan Swindells, MBBS University of Nebraska
University of Nebraska
September 2017