An observational study in HIV-Associated Cognitive Motor Complex, sponsored by National Institute of Mental Health (NIMH). Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by National Institute of Mental Health (NIMH) · Observational
Background:
Objectives:
Eligibility:
Design:
Objective:
To determine the relationship among neuroinflammation, Permeability-glycoprotein (P-gp) function and mild neurocognitive disorder (MND), a cognitive disorder associated with HIV infection.
Study Population:
HIV seropositive subjects with MND, HIV seropositive subjects with normal cognitive function, and HIV seronegative control subjects.
Design:
Subjects will undergo history and physical exam, screening laboratory tests, EKG, brain MRI and neuropsychological evaluation. HIV-seropositive subjects will be stratified based on results of neuropsychological evaluation into HIV-seropositive controls (i.e., cognitively normal) and HIV-seropositive with MND. All subjects will receive brain PET imaging with [11C]dLop after P-gp blockade to measure the function of P-gp at the blood-brain barrier. P-gp will be blocked prior to the PET scan with tariquidar. HIV-seropositive subjects will receive one lumbar puncture at baseline and one lumbar puncture after P-gp blockade with tariquidar to measure CSF concentrations of anti-retroviral medications and to measure biomarkers of blood-brain barrier integrity and inflammation in the CSF. HIV-seronegative subjects will receive one lumbar puncture at baseline to measure biomarkers of blood-brain barrier integrity and inflammation in the CSF.
Outcome Measures:
The main outcome measures of the study is brain uptake of [11C]dLop in response to P-gp blockade with tariquidar. We will correct for individual metabolism of tariquidar by measuring the plasma concentration of tariquidar during the P-gp blocked scan.
As a secondary outcome measure, concentrations of anti-retroviral medications in CSF will be measured in HIV seropositive subjects with and without MND. CSF concentrations will be used as a surrogate marker for CNS delivery of anti-retroviral drugs.
Subjects must be between 18 and 60 years of age.
For HIV seropositive subjects:
Specific inclusion criteria for mild neurocognitive disorder are as follows:
EXCLUSION CRITERIA:
Note: The rationale for the exclusion criteria for alcohol use is to avoid alcohol-related cognitive impairment as a confounding factor.
Brain uptake of [11C]dLop after pharmacological challenge with the P-gp inhibitor tariquidar.
Cerebrospinal fluid concentrations of antiretroviral drugs and inflammatory markers.
This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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National Institute of Mental Health (NIMH)