PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
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.
⁃ Study Phase 1
• Age ≥18 years, and
• HIV uninfected, or
• HIV infection, and
• has an HIV viral load measurement within 12 months of study entry of \>40 copies/mL, and
• HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activity (HIV infected participants only)
⁃ Study Phase 2
• Age ≥18 years, and
• HIV infection, and
• Initiated a combination ART regimen and has HIV viral load measurements below the detection limit of a clinically approved PCR-based assay (e.g. \<40 HIV-1 RNA copies/mL of blood), or
• HIV infection, and
• has an HIV viral load measurement within 12 months of study entry of \>40 copies/mL, and
• HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activity, or
• HIV uninfected