Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Timothy J Henrich

Description

Summary

This is a single center exploratory imaging study involving one intravenous microdose of [18F]F-AraG followed by whole-body positron emission tomography-magnetic resonance (PET-MR) imaging in HIV infected individuals to determine the anatomical distribution of the PET tracer. Participants will be enrolled if they were treated during early or late HIV infection. In addition, individuals not on antiretroviral therapy (ART) or with HIV-1 plasma RNA levels >5,000 copies/mL will be enrolled.

Official Title

Imaging Immune Activation in HIV Infection

Details

The PET radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine; trade name VisAcT) localizes to sites of immune activation and is predominantly accumulated in proliferative T cells. As a result, there is interest in imaging residual immune activation in the setting of both treated and untreated HIV-1 infection, a disease in which chronic immune activation and inflammation may lead to significant morbidity, despite the use of otherwise suppressive ART.

The primary endpoint is to determine the anatomical distribution of [18F]F-AraG in HIV-infected individuals taking or not taking antiretroviral therapy.

Secondary objectives are to determine if [18F]F-AraG PET-MRI is able to detect differences in T cell activation between patients with early versus late treated HIV infection and to determine if [18F]F-AraG uptake correlates with direct blood and tissue measures of HIV reservoir size and activity in the above cohorts/studies.

Keywords

HIV Infections HIV infection Positron Emission Tomography F-AraG Magnetic Resonance Imaging Infection Acquired Immunodeficiency Syndrome [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) [18F]F-AraG

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age >18 years
  2. Ability to read and understand written informed consent document
  3. HIV infection, and Initiated a combination ART regimen, or, has never received ART,or, has received ART in the past, but has not been taking for a least 1 month prior to enrollment

You CAN'T join if...

  1. Any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia
  2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
  3. Patients who are pregnant (female patients of childbearing age will be tested prior to injection of imaging agent - positive test will exclude from participating in the study)
  4. Patients who are breastfeeding
  5. Patients who have had prior allogeneic stem cell or solid organ transplant
  6. Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute,aspartate aminotransferase >100 units/L, alanine aminotransferase >100 units/L.
  7. Absolute CD4+ T cell count <100 cells/μL (HIV infected individuals only)
  8. Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months
  9. Current HIV-related opportunistic infection such as pneumocystis pneumonia,disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (limited oral thrush acceptable) and cerebral toxoplasmosis
  10. . Previously diagnosed myelodysplasia syndrome. or history of lymphoproliferative disease prior to study entry
  11. . History of congestive heart failure as defined by physician documentation in the medical record at any time prior to screening that required medication for heart failure or that required medical management within 1 year prior to study entry
  12. . Vaccination within 14 days of study entry

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94110 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03684655
Phase
Phase 1
Lead Scientist
Timothy J Henrich
Study Type
Interventional
Last Updated