PET Imaging with VRC01 for HIV-1 Infection

This study is looking at how a special imaging agent, called [89]Zr-DFO-VRC-HIVMAB060-00-AB, moves through the body in people with HIV-1 and healthy volunteers. This agent is a monoclonal antibody (a type of protein that can find and attach to specific targets) that is designed to target the HIV-1 virus. Researchers want to understand how much of this agent goes to different parts of the body and how long it stays there. This is not a treatment study, but rather an exploratory imaging study to learn more about how this agent behaves in the body. To join, you must be at least 18 years old. If you have HIV, your viral load (the amount of virus in your blood) must have been over 40 copies/mL in the last year, and your HIV-1 virus should be of a type that VRC01 can bind to. The study aims to measure the distribution of the imaging agent in the body over 120 hours.

Study design
This is an interventional study with a planned enrollment of 30 participants. It involves two phases, with the second phase depending on results from the first.
What's involved
You would receive one intravenous (IV) microdose of the imaging agent and then undergo up to four whole-body PET-MR (Positron Emission Tomography - Magnetic Resonance) scans over 72-120 hours.
Compensation
Not stated in the trial record.
Follow-up
Your body's exposure to the imaging agent will be measured for up to 120 hours after it is given.

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NCT03729752

PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
University of California, San Francisco
~30 participants
Updated 2025-06-05 on ClinicalTrials.gov
What's tested:[89]Zr-DFO-VRC-HIVMAB060-00-AB

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dosimetry of 89Zr-DFO-VRC01 in healthy volunteers and HIV-infected participants.
Measured over 120 hours
+1 more outcome measured
HIV-1-infection
1 sites across 1 states
California1
  • Timothy Henrich, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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  • Dosimetry of 89Zr-DFO-VRC01 in healthy volunteers and HIV-infected participants.120 hours

    To determine the dosimetry and whole body distribution of 89Zr-DFO-VRC01 in healthy volunteers and HIV-infected participants. Study Phase 1.

  • 89Zr-DFO-VRC01 temporal uptake in healthy controls and HIV-infected participants with viral load >1000 c/mL.120 hours

    To determine the differences in 89Zr-DFO-VRC01 temporal uptake in tissues in healthy volunteers versus HIV-infected, viremic participants. Study Phase 1.