Brain Imaging for HIV-Associated Thinking and Mood Disorders

This study is currently recruiting participants.
Verified June 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01692236
First received: September 20, 2012
Last updated: March 14, 2014
Last verified: June 2013

September 20, 2012
March 14, 2014
September 2012
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Neuropsychologic testing scores [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01692236 on ClinicalTrials.gov Archive Site
  • 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 ]
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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.

HIV/AIDS has been transformed from an inevitably fatal, progressive infection to a manageable chronic condition. Yet, HIV associated neurocognitive disorders (HANDs) and major depressive disorder (MDD) continue to pose a significant clinical problem, even among patients with well-controlled viremia. There is also growing evidence of accelerated vascular aging and other types of vascular abnormalities in HIV-infected (HIV+) people, and preliminary evidence suggests their association with 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 intra- and extracranial vessel walls. Forty HIV+ participants and 40 HIV-negative controls will be recruited. HIV+ participants who consent to longitudinal follow-up will be followed for a total of 4 years starting from the initial presentation, with evaluations every 6 months. HIV-negative participants will be followed for 1 additional year to provide comparison data. Cross-sectional data analysis will examine the vascular and neurocognitive markers in both groups of participants. The longitudinal data analysis will assess the temporal progression of vascular disease (blood and imaging findings) in relation to changes in neurocognitive and depression scores in both groups.

Observational
Time Perspective: Prospective
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  • Human Immunodeficiency Virus
  • Neurocognitive Impairment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
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  • INCLUSION CRITERIA:

Inclusion criteria for all participants:

  1. Age 25-55 years.
  2. Willingness to allow stored samples, human leukocyte antigen (HLA) testing, and future genetic testing.
  3. 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.
  4. English language fluency (required for neuropsychological testing).

Additional inclusion criteria for HIV+ participants:

  1. Documented HIV infection by standard HIV testing. Prior documentation of HIV- antibody status at the NIH will be accepted in lieu of repeat testing.
  2. HIV viral load below the limit of detection on combination antiretroviral therapy for less than or equal to 1 year.
  3. 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:

  1. 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.
  2. Subjects requiring sedation for MRI studies.
  3. Subjects with a condition precluding entry into scanner and acquisition of scans (e.g., morbid obesity, claustrophobia, back pain, motion disorders).
  4. Chronic renal insufficiency defined as a glomerular filtration rate < 30 mL/min/1.73 m(2) as estimated using the Modified Diet in Renal Disease equation.
  5. Evidence of current or prior central nervous system opportunistic infection(s) and/or space-occupying lesions such as primary CNS lymphoma.
  6. Prior history of intrathecal chemotherapy or radiation therapy to the brain.
  7. History of or current diagnosis of systemic vasculitis.
  8. Active systemic infection or malignancy requiring therapy.
  9. Psychiatric condition interfering with ability to participate in study procedures or provide informed consent.
  10. Patient or provider report of alcohol or drug abuse ongoing or within 3 months prior to participation.
  11. Sickle cell disease (due to known association with vasculopathy).
  12. Systolic blood pressure less than or equal to 180 mmHg at screening.
  13. Persons infected with hepatitis C virus (HCV) who are being treated or planning to seek treatment for HCV.
  14. Women who are lactating, pregnant, or actively seeking to become pregnant.
  15. 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).

Both
25 Years to 55 Years
Yes
Contact: Cheryl L. Chairez (301) 496-3840 chairezc@mail.nih.gov
Contact: Caryn G Morse, M.D. (301) 496-9320 cmorse@mail.nih.gov
United States
 
NCT01692236
120200, 12-CC-0200
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National Institutes of Health Clinical Center (CC)
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Caryn G Morse, M.D. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP