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

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ClinicalTrials.gov Identifier: NCT01186042
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Swindells, MBBS, University of Nebraska

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
HIV Aging Other: Observational

Detailed Description:

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.


Study Design
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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)
Study Start Date : August 2010
Actual Primary Completion Date : December 17, 2014
Actual Study Completion Date : December 17, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Aging in HIV
20-40 years of age or older than 50
 Other: Observational
No intervention


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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;


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

    Secondary objective includes:

    Participant acceptance of the measures involved;


  3. 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.



Biospecimen Retention:   Samples Without DNA
plasma

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University of Nebraska Medical Center HIV Clinic
Criteria

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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186042


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Susan Swindells, MBBS University of Nebraska
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
University of Nebraska Medical Center HIV Clinic  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Susan Swindells, MBBS, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01186042     History of Changes
Other Study ID Numbers: 396-10-FB
P30MH062261 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Susan Swindells, MBBS, University of Nebraska:
HIV
Aging
Neuropsychological function
Activity
 Sleep patterns
Frailty
Emotional well-being
Sexual health

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