Actively Recruiting
Thinking and Memory Problems in People With HIV
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-13
1150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: \- People with human immunodeficiency virus (HIV) can sometimes develop thinking and memory problems. These problems can vary widely, from few symptoms to severe problems with memory and concentration. It initially was thought that good HIV treatment could prevent almost all HIV-related memory problems. However, even people with low HIV viral loads can have these problems. It may be caused by HIV affecting the brain and spinal fluid. It is not yet clear why HIV causes these problems and why they may be worse in some people than others. Researchers want to study people with HIV and healthy volunteers to see how HIV may affect people with only small amounts of the virus in their blood. Objectives: \- To study thinking and memory problems in individuals with HIV that is otherwise controlled with medications. Eligibility: * Individuals between 18 of age or older whose HIV has been controlled with medications for at least 1 year. * Healthy volunteers between 18 of age or older. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. A neurological test will also be given. Participants will have a baseline imaging study of the brain. * Within 12 weeks of the first visit, participants will have a second visit. Additional blood samples will be drawn. Another brain imaging study will be performed. * Within 8 weeks of the second visit, participants will have a third visit to collect more blood samples. They will also provide spinal fluid samples, either as a single visit or a longer procedure. * After this visit, participants will return every 12 months for up to 10 years. Blood samples will be collected as needed at these visits. Thinking and memory tests and imaging studies may also be given as needed. Spinal fluid may be collected at one visit a year.
CONDITIONS
Official Title
Thinking and Memory Problems in People With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older
- Able to sign informed consent
- At least seventh grade education and able to speak, read, and understand English
- Consent to store blood and tissue samples
- Willing to participate for up to 20 years
- For HIV-positive participants: documented HIV-1 infection
- Must have a primary medical doctor providing care
- Plasma HIV-RNA below 50 copies/mL or below limit of detection for over one year
- At least one year of continuous antiretroviral therapy
- For HIV-negative controls: HIV-antibody negative; may be taking pre-exposure prophylaxis (PrEP)
You will not qualify if you...
- Illness or condition that may interfere with participation, including active CNS infections
- History of non-CNS opportunistic infections unless fully recovered and back to baseline activity
- Conditions associated with cognitive impairment unrelated to HAND, such as Alzheimer's or Parkinson's
- Head injury with loss of consciousness over 30 minutes
- Untreated sleep apnea with daytime sleepiness
- Active seizure disorders unless stable and on non-sedating medication for over 6 months
- Severe unstable psychiatric illness that may affect participation or data
- Active substance abuse including illegal drugs or excessive alcohol use
- Contraindications to MRI such as pacemakers, brain stimulators, metallic implants, or shrapnel
- Use of narcotics, psychiatric, or anti-seizure medications except under stable conditions
- Pregnancy or positive pregnancy test within 48 hours prior to MRI or radiation exposure
- Prior or planned radiation exposure exceeding recommended annual limits due to clinical care or other research participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Amanda M Wiebold
CONTACT
A
Avindra Nath, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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