Brain Imaging for HIV-Associated Thinking and Mood Disorders

Stopped early

Conditions studied: Human Immunodeficiency Virus, Neurocognitive Impairment

In brief

Background: \- 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. Objectives: * 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. Eligibility: * Individuals between 25 and 55 years of age who have HIV infection. * Healthy individuals between 25 and 55 years of age. Design: * 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.

Key facts

Study ID

NCT01692236

Run by

National Institutes of Health Clinical Center (CC)

People needed

84

Starts

2012-09-13

Expected to finish

2018-04-04

Last updated by the study team

2019-12-05

Who can join

Age: 25 and older, up to 61. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Exclusion criteria for all participants:
• Contraindication to MRI scanning, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments.
• Subjects with a condition precluding entry into scanner and acquisition of scans (e.g., morbid obesity, claustrophobia, back pain, motion disorders).
• Glomerular filtration rate <45 mL/min/1.73 m(2) as estimated using the Modified Diet in Renal Disease equation.
• Allergy to qadolinium (MRI contrast)
• Evidence of current or prior central nervous system opportunistic infection(s) and/or space-occupying lesions such as primary CNS lymphoma.
• Prior history of intrathecal chemotherapy or radiation therapy to the brain.
• History of or current diagnosis of systemic vasculitis.
• Active systemic infection or malignancy requiring therapy.
• Psychiatric condition interfering with ability to participate in study procedures or provide informed consent.
• Patient or provider report of alcohol or drug abuse ongoing or within 3 months prior to participation.
• Sickle cell disease (due to known association with vasculopathy).
• Systolic blood pressure less than or equal to 180 mmHg at screening.
• Persons infected with hepatitis C virus (HCV) who are being treated or planning to seek treatment for HCV.
• Women who are lactating, pregnant, or actively seeking to become pregnant.
• Other known clinical condition or conditions discovered on MRI that, at the discretion of the investigators, precludes serial clinical, neuropsychological, or imaging evaluation.
• Additional exclusion criteria for HIV+ participants
• HIV acquired perinatally (due to potential effects of HIV and antiretroviral therapy on neurocognitive and vascular development).

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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