MR Imaging and MR Spectroscopy of HIV

NCT05219279 | Unknown

• 1 other identifier: 20-001739
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

MR Spectroscopy; central nervous system

Outcome Measures

Primary Outcomes (1)

• Spectroscopy outcomes

  (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

  One year

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• HIV negative

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Albert Thomas, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Rueda, MPH

CONTACT

310-562-9694; vrueda@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-in-Residence

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 2, 2022
• Study Start: May 16, 2022
• Primary Completion: July 9, 2023
• Study Completion: March 31, 2024
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

US (1)