Thinking and Memory Problems in People With HIV
ConditionHIV Positive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
18 years of age and older.
Ability to sign informed consent by the participant.
At least seventh grade educational level and ability to speak, read, and understand English. Education level will be assessed by participant self-report. Because many of the neuropsychological subtests were validated using United States norms, participants must be native English speakers or if foreign-born, demonstrate ability to understand the English language at the time of protocol consent and neuropsychological testing.
Consent to store blood and tissue.
Disqualifiers
CNS infections: this includes but is not limited to Varicella zoster virus (VZV) encephalitis, CNS lymphoma and toxoplasmosis. Participants who have recovered from effectively treated CNS infections may be considered once they resume baseline daily activities.
Non-CNS opportunistic infections: Participants who recovered from or are completing treatment for non-CNS opportunistic infections (Ois) (e.g., Pneumocystis pneumonia, Candida esophagitis, or pulmonary TB) can be enrolled if they have returned to self-reported baseline activity and functional level.
Conditions other than HAND associated with cognitive impairment or dementia such as Alzheimer's, Parkinson's disease, head injury with loss of consciousness >30 minutes, untreated sleep apnea with day-time sleepiness, or seizure disorders. Participants with a history of seizure disorder with no seizure activity that are on a stable, non-sedating anti-seizure regimen for >6 months may be enrolled.
Concurrent severe, unstable psychiatric illness that, in the opinion of the investigators, may interfere with study participation and/or data interpretation. Participants on psychotropic anxiolytic, attention deficit-hyperactivity disorder (ADHD), and other psychiatric medications may be included if clinically stable for 6 months.
Trial population
Any person meeting eligibility criteria and has no exclusionary criteria will be considered for the study.@@@
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,150 Participants
are grouped into 3 trial groupsGroup A: DOD
Group B: HIV negative controls
Group C: HIV positive
Trial outcomes
Primary outcomes
1
To characterize in detail the natural course of HAND in subjects with prolonged plasma HIV virologic suppression (<50 copies/mL).
The prevalence of neurocognitive impairment in this cohort will be high despite HIV plasma viremia below the limit of detection (BLD) in the blood as chronic activation may be mediating neuronal damage and result in cognitive impairment.
Time frame
AnnuallySponsors and contacts
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Source ClinicalTrials.gov