Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)

NCT01186042 | Completed

• 2 other identifiers: 0396-10-FBP30MH062261
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Aging

Keywords

HIV; Aging; Neuropsychological function; Activity; Sleep patterns; Frailty; Emotional well-being; Sexual health

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of enrolling older HIV-infected patients and younger controls into a prospective, observational study.

  Evaluate the feasibility of enrolling older HIV-infected patients and youger controls into a prospective, observational study.

  One month

Secondary Outcomes (3)

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

  One month

• Participant acceptance of the measures involved

  One month

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

  One month

Study Arms (1)

Aging in HIV

20-40 years of age or older than 50

Other: Observational

Interventions

Observational OTHER

No intervention

Aging in HIV

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University of Nebraska Medical Center HIV Clinic

You may qualify if:

• Diagnosed with HIV infection.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• 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. doi: 10.1212/01.wnl.0000134665.58343.8d.

  PMID: 15365130 BACKGROUND

Related Links

• University of Nebraska Medical Center HIV Clinic

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Motor Activity; Frailty

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Susan Swindells, MBBS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: August 20, 2010
• Study Start: August 1, 2010
• Primary Completion: December 17, 2014
• Study Completion: December 17, 2014
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

US (1)