Actively Recruiting
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
Led by University of California, San Francisco · Updated on 2025-06-05
30
Participants Needed
1
Research Sites
421 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
A
amfAR, The Foundation for AIDS Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single center exploratory imaging study involving one intravenous microdose of 89Zr-DFO-VRC01 followed by whole-body PET-MR imaging in HIV infected individuals and healthy volunteers. Imaging data will be obtained from up to four static PE-MR images in order to determine dosimetry and temporal tissue uptake/tissue distribution of 89Zr-DFO-VRC01. This is not a treatment study of the biological activity of 89Zr-DFO-VRC01 to impact HIV persistence.
CONDITIONS
Official Title
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- HIV uninfected, or
- HIV infection with a viral load measurement within 12 months of study entry greater than 40 copies/mL
- HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activity (for HIV infected participants)
- For Phase 2, HIV infected individuals on combination ART with viral load below detection limit of clinical PCR assay, or HIV infected with viral load greater than 40 copies/mL, or HIV uninfected
You will not qualify if you...
- Contraindications to MRI such as permanent pacemaker, implantable metallic device/prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia
- Any medical condition that would interfere with imaging acquisition
- Participation in a radiation study within 6 months (Phase 1) or 12 months (Phase 2)
- Pregnancy or positive pregnancy test prior to imaging agent injection
- Screening lab values: absolute neutrophil count less than 1,000 cells/mm3, platelet count less than 70,000 cells/mm3, hemoglobin less than 8 mg/dL, creatinine clearance less than 40 mL/min, AST or ALT greater than 100 units/L
- Absolute CD4+ T cell count less than 100 cells/µL (HIV infected individuals only)
- Serious illness requiring hospitalization or parental antibiotics within the past 3 months
- Current HIV-related opportunistic infections such as pneumocystis pneumonia, disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (except limited oral thrush), or cerebral toxoplasmosis
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 Henrich, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here