RecruitingPhase 1NCT03729752

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

Sponsor

University of California, San Francisco

Enrollment

30 participants

Start Date

Nov 1, 2018

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria14

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

Exclusion Criteria16

Study Phase 1
Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
Patients who have had a study involving radiation within six months of enrolling in this study
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)
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.
Absolute CD4+ T cell count <100 cells/μL (HIV infected individuals only)
Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months.
Current HIV-related opportunistic infection such as pneumocystis pneumonia, disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (limited oral thrush acceptable) and cerebral toxoplasmosis
Study Phase 2
Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
Patients who have had a study involving radiation within 12 months of enrolling in this study
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)
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.
Absolute CD4+ T cell count <100 cells/μL (HIV infected individuals only)
Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months.
Current HIV-related opportunistic infection such as pneumocystis pneumonia, disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (limited oral thrush acceptable) and cerebral toxoplasmosis