Brain Imaging for HIV-Associated Thinking and Mood Disorders
- Human immunodeficiency virus (HIV) infection appears to cause problems with blood vessel function. These problems may add to some thinking and mood disorders found in people with HIV infection. Researchers want to evaluate HIV infected patients to see if blood vessel function contributes to thinking and mood disorders, such as early dementia and depression. To do so, they will compare study results between people with and people without HIV infection.
- To compare the thickness of blood vessel walls between people with and without HIV infection.
- To study the relationship between blood vessel thickness and thinking and mood disorders.
- Individuals between 25 and 55 years of age who have HIV infection.
- Healthy individuals between 25 and 55 years of age.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- Participants will have imaging studies of the brain and major blood vessels in the head and neck.
- Participants will also have neuropsychological testing. These tests will look at memory, learning and thinking ability, attention, and mood.
- Participants will have the option of coming back for repeat blood tests every six months and repeat imaging studies and neuropsychological tests every year, over 1- 4 years period.
Human Immunodeficiency Virus
|Study Design:||Time Perspective: Prospective|
|Official Title:||Neurovascular Magnetic Resonance Imaging in the Assessment of HIV-Associated Neurocognitive Disorders|
- Neuropsychologic testing scores [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
- Serum biomarkers of cardiovascular disease and inflammation [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
- MRI brain and vascular findings [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
With combination antiretroviral therapy, HIV/AIDS has been transformed from a progressive, usually fatal infection to a manageable chronic condition. Yet, HIV associated neurocognitive disorders (HAND) pose a significant clinical problem, even among patients with controlled HIV viremia. There is evidence of accelerated vascular aging and other vascular disorders in HIV-infected (HIV+) people, and studies suggest an association between vascular disorders and unfavorable neurocognitive outcomes. Thus, one possible contributing factor to the high rates of HANDs and depression could be vascular dysfunction, similar to vascular depression and vascular dementia that occur in elderly non-HIV+ individuals. One commonly used diagnostic marker of vasculopathy is thickening of the vessel wall. Multiple studies have already established the correlation between vessel wall thickening and vascular disease manifestations. This prospective observational study aims to examine the relationships between neurocognitive and depression outcomes and vessel wall thickness as a marker of vascular disease in HIV+ adults. We will be using neuropsychological testing, brain imaging, blood biomarkers, and state-of-the-art high-resolution MR imaging of the carotid vessel walls. HIV infected patients (n=40) and HIV-negative controls (n=40) will be recruited. Participants who consent to longitudinal follow-up will be followed for two years with clinical evaluations every 6 months and repeat imaging studies at 12 and 24 months. Cross sectional data analysis will compare markers of vascular and neurocognitive disorders between HIV-infected and HIV-negative participants. The longitudinal data analysis will assess and compare the temporal progression of vascular disease (imaging and blood biomarker findings) in relation to changes in neurocognitive and depression scores in both groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692236
|Contact: Cheryl L. Chairez||(301) firstname.lastname@example.org|
|Contact: Caryn G Morse, 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:||Caryn G Morse, M.D.||National Institutes of Health Clinical Center (CC)|