Recruiting

MR Imaging

Sponsor:

UCLA

Code:

NCT05219279

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT05219279

Start date

May 16, 2022

Status verified date

May, 2022

Completion date

Mar 31, 2024

Anticipated

Primary completion date

Jul 9, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Spectroscopy outcomes [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 18, 2022

Last verified

May, 2022

Keywords

  • MR Spectroscopy
  • central nervous system

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2022-05-18.