- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692236
Brain Imaging for HIV-Associated Thinking and Mood Disorders
Neurovascular Magnetic Resonance Imaging in the Assessment of HIV-Associated Neurocognitive Disorders
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Inclusion criteria for all participants:
- Age 25-61 years.
- Willingness to allow stored samples, human leukocyte antigen (HLA) testing, and future genetic testing.
- Hemoglobin less than or equal to 9.0 g/dL, HCT less than or equal to 28%, platelets less than or equal to 50,000/microL.
- English language fluency (required for neuropsychological testing).
Additional inclusion criteria for HIV+ participants:
- Documented HIV infection by standard HIV testing. Prior documentation of HIV- antibody status at the NIH will be accepted in lieu of repeat testing.
- HIV viral load below the limit of detection on combination antiretroviral therapy for less than or equal to 1 year.
- Under the care of a primary care physician.
Additional inclusion criteria for HIV-negative participants:
1. HIV-antibody negative.
EXCLUSION CRITERIA:
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
1. HIV acquired perinatally (due to potential effects of HIV and antiretroviral therapy on neurocognitive and vascular development).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neuropsychologic testing scores
Time Frame: 1-6 years
|
1-6 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum biomarkers of cardiovascular disease and inflammation
Time Frame: 1-6 years
|
1-6 years
|
MRI brain and vascular findings
Time Frame: 1-6 years
|
1-6 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Connor M. Human immunodeficiency virus (HIV) and stroke: targets for intervention. Infect Disord Drug Targets. 2010 Apr;10(2):76-83. doi: 10.2174/187152610790963483.
- Highleyman L. Mortality trends: toward a new definition of AIDS? BETA. 2005 Winter;17(2):18-28.
- Holtgrave DR. Causes of the decline in AIDS deaths, United States, 1995-2002: prevention, treatment or both? Int J STD AIDS. 2005 Dec;16(12):777-81. doi: 10.1258/095646205774988109.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Neurocognitive Disorders
Other Study ID Numbers
- 120200
- 12-CC-0200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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