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MR Imaging and MR Spectroscopy of HIV (HIV)

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ClinicalTrials.gov Identifier: NCT05219279
Recruitment Status : Recruiting
First Posted : February 2, 2022
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Information provided by (Responsible Party):
Michael Albert Thomas, Ph.D., University of California, Los Angeles

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The Center for Disease Control and Prevention estimates that 1,148,200 Americans aged 13 years and older are living with HIV infection, including 207,600 (18.1%) who are unaware of their infection. According to pathological data, central nervous system (CNS) involvement is commonly found during the early phase of infection. In vivo proton magnetic resonance spectroscopy studies of HIV-infected humans have demonstrated significant changes of metabolites observed in the brain N-acetylaspartate, creatine, choline, glutamate, glutamine and myo-inositol with varying changes in different brain regions. Diffusion tensor imaging (DTI) is a novel functional MRI technique which can be used to derive quantitative in vivo measurements of region-specific and diffuse brain alterations. DTI studies have demonstrated changes of mean diffusivity (MD) and fractional anisotropy (FA) in the various parts of brain. Diffusion abnormalities involving various regions of brain have also been observed in patients infected with HIV. One dimensional (1D) or two-dimensional (2D) magnetic resonance spectroscopic imaging (MRSI) technique has been used for many years to study the metabolites changes in HIV. MRI scan time necessary for the acquisition of high-resolution MRSI data with adequate spatial coverage may be prohibitively long for clinical exams. Thus, new imaging and bio-chemical characterization techniques are needed to allow repeated, non-invasive assessment of these processes in vivo. Since neuroinflammation is associated with increased brain water, diffusion tensor imaging (DTI) is sensitive to changes in white matter (WM) and inflammatory changes associated with HIV infections. Even though only single-voxel-based diffusion-weighted MRS has been previously investigated, altered diffusivity of non-water metabolites and its relationship with metabolic disturbance as well as structural and functional abnormalities in HIV has not been investigated. The brain apparent diffusion coefficient (ADC) changes of metabolites measured by the novel 3D MRSI technique will be correlated with the ADCs and fractional anisotrophy of water recorded by DTI and cell count to better understand the role of CNS involvement in HIV pathology.

Condition or disease
HIV Infections

Detailed Description:
This will be a multicenter prospective study. We will recruit ten (10) healthy participants aged 20 to 30 years to investigate the feasibility and test/retest reliability of the REPSI sequence. Twenty five (25) HIV+ patients will be recruited from the Division of HIV Medicine (Dr. Eric Daar) at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (Torrance, CA). HIV+ patients will be transported to the UCLA Medical center for neuroimaging examination.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Radial Diffusion-Weighted MR Spectroscopic Imaging of HIV: Biomarker Detection Using Functional Imaging and Neurocognitive Correlates
Actual Study Start Date : May 16, 2022
Estimated Primary Completion Date : July 9, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort
HIV+ participants
  • HIV-infected between age of 20 and 65 years
  • Consistently have plasma HIV RNA levels <200 copies/mL for at least the last 12 months on a stable antiretroviral regimen with any changes made only for convenience, safety or simplicity.
HIV- participants
25 age- and sex- matched HIV- subjects (healthy) will be recruited also at the UCLA Medical center who will undergo the neuroimaging examination.


Outcome Measures
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Primary Outcome Measures :
  1. Spectroscopy outcomes [ Time Frame: One year ]
    (1) Develop accelerated r-DW-EPSI using semi-LASER localization (33), and optimize the protocol in brain phantom solutions and 10 healthy adults. (2) Determine ADCs of Cr, NAA, Cho, mI and Glx in 25 adult HIV patients on ART, and evaluate differences in 25 age-/sex-matched HIV- adults. Outcomes will be correlated with DTI metrics, neuropsychological test results, and other disease variables


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
25 HIV-infected, virologically suppressed and 25 age- and sex- matched HIV- subjects (healthy) will be recruited also at the UCLA Medical center who will undergo the neuroimaging examination.
Criteria

Inclusion Criteria:

  • HIV-infected between age of 20 and 65 years
  • Consistently have plasma HIV RNA levels <200 copies/mL for at least the last 12 months on a stable antiretroviral regimen with any changes made only for convenience, safety or simplicity.
  • Able to provide informed consent.

Exclusion Criteria:

-HIV negative

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219279


Contacts
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Contact: Victoria Rueda, MPH 310-562-9694 vrueda@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Victoria Rueda    310-562-9694    vrueda@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Investigators
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Principal Investigator: Albert Thomas, PhD University of California, Los Angeles
More Information
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Responsible Party: Michael Albert Thomas, Ph.D., Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05219279    
Other Study ID Numbers: 20-001739
First Posted: February 2, 2022    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Albert Thomas, Ph.D., University of California, Los Angeles:
MR Spectroscopy
central nervous system
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases