Actively Recruiting
Imaging Immune Activation in HIV by PET-MR
Led by CellSight Technologies, Inc. · Updated on 2024-10-24
30
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
Sponsors
C
CellSight Technologies, Inc.
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Up to 30 participants will be enrolled with HIV.
CONDITIONS
Official Title
Imaging Immune Activation in HIV by PET-MR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Ability to read and understand the informed consent document
- Diagnosed with HIV infection
- Either currently on combination ART, never received ART, or stopped ART at least 1 week before imaging
- Recent lab tests within 60 days showing platelet count of at least 100,000/mm3
- Absolute neutrophil count greater than 1500/mm3
- Liver enzymes (AST and ALT) less than twice the upper limit of normal
- CD4+ T cell count greater than 100 cells/mm3 for HIV infected individuals
- Kidney function with creatinine clearance of at least 60 mL/min estimated by Cockcroft-Gault equation
You will not qualify if you...
- Contraindications to MRI such as permanent pacemaker, metallic implants, aneurysm clips, non-removable piercings, or severe claustrophobia
- Any medical condition that would interfere with imaging as judged by the investigator
- Use of systemic immune modifying therapy within 60 days prior to enrollment (except HIV DNA vaccine)
- Pregnancy or breastfeeding
- Female participants of reproductive potential must have negative pregnancy tests before imaging and use two forms of birth control
- Prior allogeneic stem cell or solid organ transplant
- Low blood counts: neutrophils less than 1500/mm3, platelets less than 100,000/mm3, hemoglobin less than 8 mg/dL
- Kidney function below 60 mL/min creatinine clearance
- Elevated liver enzymes above twice the upper limit of normal
- Serious illness requiring hospitalization or intravenous antibiotics within the past 3 months
- Current HIV-related opportunistic infections such as pneumocystis pneumonia, disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (except mild oral thrush), or cerebral toxoplasmosis
- History of myelodysplasia syndrome or lymphoproliferative disease
- History of congestive heart failure requiring medication or recent medical management
- Active Hepatitis C infection (prior treated HCV allowed)
- Active systemic autoimmune diseases
- Recent clinical vaccination within 14 days prior to study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
T
Timothy J Henrich, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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