Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01186042
First received: July 22, 2010
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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 Intervention
HIV
Aging
Other: Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Evaluate the feasibility of enrolling older HIV-infected patients and younger controls into a prospective, observational study. [ Time Frame: One month ] [ Designated as safety issue: No ]
    Evaluate the feasibility of enrolling older HIV-infected patients and youger controls into a prospective, observational study.


Secondary Outcome Measures:
  • Selection of the optimal test battery to measure the areas of interest [ Time Frame: One month ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    Secondary objective includes:

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



Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aging in HIV
20-40 years of age or older than 50
Other: Observational
No intervention

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT01186042

Contacts
Contact: Frances G. Van Meter, APRN 402-559-8163 fvanmete@unmc.edu
Contact: Jennifer L. O'Neill, RN, BSN 402-559-4408 jloneill@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Frances G. Van Meter, APRN    402-559-8163    fvanmete@unmc.edu   
Contact: Jennifer L. O'Neill, RN, BSN    402-559-4408    jloneill@unmc.edu   
Principal Investigator: Susan Swindells, MBBS         
Sub-Investigator: Uriel S. Sandkovsky, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Susan Swindells, MBBS University of Nebraska
  More Information

Additional Information:
Publications:
Responsible Party: Susan Swindells, MBBS/Principal Investigator, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01186042     History of Changes
Other Study ID Numbers: 396-10-FB, P30MH062261
Study First Received: July 22, 2010
Last Updated: August 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on October 16, 2014