Thinking and Memory Problems in People With HIV
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|ClinicalTrials.gov Identifier: NCT01875588|
Recruitment Status : Recruiting
First Posted : June 12, 2013
Last Update Posted : November 24, 2017
- 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.
- To study thinking and memory problems in individuals with HIV that is otherwise controlled with medications.
- Individuals between 18 and 61 years of age whose HIV has been controlled with medications for at least 1 year.
- Healthy volunteers between 18 and 61 years of age.
- 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 6 months for up to 5 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.
|Condition or disease|
|Acquired Immunodeficiency Neurocognitive Disorders|
The natural history of neurocognitive impairment in human immunodeficiency virus (HIV)-infected individuals remains poorly understood. While the advent of highly active antiretroviral therapy (HAART) has led to a decreased incidence of the most severe form of HIV associated neurocognitive disorders (HAND), HIV-associated dementia, it does not appear to have impacted overall prevalence of HAND. Existing evidence suggests that the central nervous system (CNS) could be an important reservoir for HIV regardless of cumulative time on treatment. This 8 year multi-institute screening protocol will identify approximately 200 HIV-infected individuals and 100 healthy volunteers for enrollment in multiple HAND studies at the National Institutes of Health (NIH). Subjects will undergo a one-time screening and evaluation assessment, which will include neuropsychological testing, optical coherence tomography (OCT) and brain magnetic resonance imaging (MRI) and may include a more detailed ophthalmic evaluation.
Those who meet eligibility criteria will be offered enrollment and co-enrollment into active HIV-associated neurocognitive disorder protocols, including the natural history study presented here. This observational study will characterize the natural course of HAND in subjects with HIV viral loads <200 copies/mm(3). Subjects will be followed every 6 months for 5 years and will undergo follow-up neuropsychological testing, OCT and brain MRI as well as positron emission tomography/computed tomography (PET/CT) imaging and lumbar puncture or optional drain Those who received a detailed ophthalmic evaluation may receive similar follow-up annual evaluations.
Cerebrospinal fluid (CSF) markers of immune activation, chronic monocyte activation, cytomegalovirus/Epstein-Barr virus (CMV/EBV) infection/reactivation, and neuronal injury will be collected. In addition, HIV viral load and genotype, genetic susceptibility factors and CNS penetration-effectiveness score (CPE) and CSF levels of antiretroviral drugs will be assessed. A repository of cryopreserved biological samples will be developed and used for validation of candidate biomarkers in future studies. Collection and analysis of these data will not only enhance understanding of the CNS as a potential HIV reservoir in virally-controlled individuals but will further define the association among cortical thickness, biomarkers and neurocognitive function in an aging HIV-infected population.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Screening and Recruitment for HIV-associated Neurocognitive Disorders (HAND) Studies and an Evaluation of HIV-associated Neurocognitive Disorders in Virologically Controlled Patients|
|Study Start Date :||June 11, 2013|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
- To characterize in detail the natural course of HAND in subjects with low CD4 nadir (<200 cells/mm(3)) and prolonged plasma HIV virologic suppression (<50 copies/mL). [ Time Frame: 8 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875588
|Contact: Amanda M Wiebold||(301) firstname.lastname@example.org|
|Contact: Avindra Nath, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Avindra Nath, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|