RecruitingNCT01875588

Thinking and Memory Problems in People With HIV

An Evaluation of HIV-associated Neurocognitive Disorders (HAND) in Virologically Controlled Patients


Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Enrollment

1,150 participants

Start Date

Jul 8, 2013

Study Type

OBSERVATIONAL

Conditions

Summary

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....


Eligibility

Min Age: 18 YearsMax Age: 110 Years

Plain Language Summary

Simplified for easier understanding

This long-term study (up to 20 years) examines how HIV infection affects thinking, memory, and brain function over time, including in people whose HIV is well controlled on medication, to better understand and ultimately prevent HIV-related cognitive problems. **You may be eligible if...** - You are 18 or older and able to sign consent - You have at least a 7th grade education and can read and understand English - You are HIV positive with a well-controlled virus on antiretroviral therapy (ART) for at least 1 year, OR you are HIV negative (as a comparison participant) - You are willing to participate in follow-up visits for up to 20 years **You may NOT be eligible if...** - You have an active brain infection or a condition other than HIV that causes cognitive decline (such as Alzheimer's disease or Parkinson's disease) - You have unstable psychiatric illness or active substance abuse that would interfere with testing - You have a pacemaker or metal implants that prevent MRI scanning - You are pregnant (due to MRI and possible radiation exposure) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01875588