Brain Imaging for HIV-Associated Thinking and Mood Disorders

NCT01692236 | Terminated

• 2 other identifiers: 12020012-CC-0200
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Immunodeficiency Virus; Neurocognitive Impairment

Keywords

MRI; HIV; Neurocognitive Disorders; Major Depression; Vasculopathy

Outcome Measures

Primary Outcomes (1)

• Neuropsychologic testing scores

  1-6 years

Secondary Outcomes (2)

• Serum biomarkers of cardiovascular disease and inflammation

  1-6 years

• MRI brain and vascular findings

  1-6 years

Eligibility Criteria

• Age: 25 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.
• \. HIV-antibody negative.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 20166974 BACKGROUND

• Highleyman L. Mortality trends: toward a new definition of AIDS? BETA. 2005 Winter;17(2):18-28.

  PMID: 15828120 BACKGROUND

• 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.

  PMID: 16336756 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Neurocognitive Disorders; Depressive Disorder, Major; Vascular Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mental Disorders; Depressive Disorder; Mood Disorders; Cardiovascular Diseases

Study Officials

• Avindra Nath, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 25, 2012
• Study Start: September 13, 2012
• Study Completion: April 4, 2018
• Last Updated: December 5, 2019

Record last verified: 2018-04-04

Locations

US (1)