MR Imaging and MR Spectroscopy of HIV

NCT ID: NCT05219279

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-16

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Michael Albert Thomas, Ph.D.

Professor-in-Residence

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albert Thomas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria Rueda, MPH

Role: CONTACT

310-562-9694

Facility Contacts

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Victoria Rueda

Role: primary

310-562-9694

Other Identifiers

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20-001739

Identifier Type: -

Identifier Source: org_study_id

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