Thinking and Memory Problems in People With HIV
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ClinicalTrials.gov Identifier: NCT01875588 |
Recruitment Status
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Recruiting
First Posted
: June 12, 2013
Last Update Posted
: March 29, 2018
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Tracking Information | |||||||||
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First Submitted Date | June 11, 2013 | ||||||||
First Posted Date | June 12, 2013 | ||||||||
Last Update Posted Date | March 29, 2018 | ||||||||
Study Start Date | June 11, 2013 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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 ] | ||||||||
Original Primary Outcome Measures |
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 ] | ||||||||
Change History | Complete list of historical versions of study NCT01875588 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||
Current Other Outcome Measures | Not Provided | ||||||||
Original Other Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Thinking and Memory Problems in People With HIV | ||||||||
Official Title | Screening and Recruitment for HIV-associated Neurocognitive Disorders (HAND) Studies and an Evaluation of HIV-associated Neurocognitive Disorders in Virologically Controlled Patients | ||||||||
Brief 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:
Design:
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Detailed Description | 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. |
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Study Type | Observational | ||||||||
Study Design | Time Perspective: Retrospective | ||||||||
Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Not Provided | ||||||||
Study Population | Not Provided | ||||||||
Condition |
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Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Not Provided | ||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
600 | ||||||||
Original Estimated Enrollment |
250 | ||||||||
Estimated Study Completion Date | December 31, 2022 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
INCLUSION CRITERIA: All Subjects (HIV-infected and Healthy Controls): While different individual HIV neurocognitive studies have specific selection criteria, especially related to HIV viral load and antiretroviral therapy, inclusion criteria for this overarching protocol will be flexible in order to identify the broadest base of potential enrollees possible. An upper age limit of 61 years old will be used because changes in neurocognitive function occur more commonly in the general population after this age.
HIV-infected Only:
Healthy Controls Only: 1.HIV-antibody negative EXCLUSION CRITERIA: Screening Study (all participants):
ELIGIBILITY CRITERIA FOR PART II NATURAL HISTORY STUDY: INCLUSION CRITERIA: Natural History Study (HIV-infected Individuals): In addition to the inclusion criteria for the screening study (see above)
Natural History Study (Healthy Controls Only):
PARTICIPANT EXCLUSION CRITERIA: In addition to the exclusion criteria from the screening protocol (see section above):
EXCLUSION OF PREGNANT OR LACTATING WOMEN: The study requires exposure to high magnetic fields and irradiation, which could pose a risk to the fetus. Futher, we will be studying growth factors and inflammatory mediators in blood and CSF all of which will be affected by the state of pregnancy and then post partum state. Women who are lactating are excluded because the study may result in transfer of radioactive tracer in breast milk. EXCLUSION OF CHILDREN:: Subjects younger than 18 years of age are excluded because the developing brain is not within the scope of this study. |
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Sex/Gender |
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Ages | 18 Years to 61 Years (Adult) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT01875588 | ||||||||
Other Study ID Numbers | 130149 13-N-0149 |
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Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) | ||||||||
Study Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | November 17, 2017 |