- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01186042
Chronic HIV Infection and Aging in NeuroAIDS (CHAIN) (CHAIN)
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Aging in HIV
20-40 years of age or older than 50
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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; |
One month
|
Participant acceptance of the measures involved
Time Frame: One month
|
Secondary objective includes: Participant acceptance of the measures involved; |
One month
|
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. |
One month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan Swindells, MBBS, University of Nebraska
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- 0396-10-FB
- P30MH062261 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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