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Human Immunodeficiency VirusNCT01692236

Brain Imaging for HIV-Associated Thinking and Mood Disorders

An observational study of Human Immunodeficiency Virus and Neurocognitive Impairment, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 61 yearsHealthy volunteers can take part
How many people
84 participants
Where
1 siteUnited States
Study dates
13 Sep 2012to 4 Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 61 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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.
Read more

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.
Read the detailed description

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.

Keywords
MRI, HIV, Neurocognitive Disorders, Major Depression, Vasculopathy
Medical subject headings
Acquired Immunodeficiency Syndrome, Neurocognitive Disorders, Depressive Disorder, Major, Vascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychologic testing scores

    Measured: 1-6 years

Secondary outcomes (2)

  1. Serum biomarkers of cardiovascular disease and inflammation

    Measured: 1-6 years

  2. MRI brain and vascular findings

    Measured: 1-6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2012 (estimated)
  2. Study start13 Sep 2012
  3. Study completion4 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01692236
Sponsor's protocol ID
120200
Other IDs
12-CC-0200
Status last verified
4 Apr 2018
First submitted
20 Sep 2012
Last updated
5 Dec 2019
Results posted
No

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.

    PubMed 20166974

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

    PubMed 15828120

  • 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.

    PubMed 16336756

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus and Neurocognitive Impairment, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropsychologic testing scores (time frame: 1-6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01692236, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.

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