Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion:
Timothy Henrich

Description

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.

Details

This will be a single-center pilot study to determine dosimetry and tissue uptake/distribution and pharmacokinetics of 89Zr-VRC01. Up to 18 uninfected and HIV-infected subjects who are either taking or not taking ART will receive a small IV dose of 89Zr-VRC01. After administration of IV 89Zr-VRC01, subjects will undergo up to 4 whole body PET/MR imaging at 2, 6, 24 and 72-120h to determine the pharmacokinetics and radiation dose exposure. The study involves two phases with the second phase only to be performed only if a difference between PET activity in one or more region of interest can be determined between participant groups Phase I (HIV infected, viremic participants and healthy volunteers). Initially, up to 6 individuals with plasma HIV RNA levels >1,000 copies/ml and up to 6 HIV-uninfected individuals will be administered 89Zr radiolabeled VRC01 followed by PET-MR imaging as above (Phase 1). If differences in PET activity in one or more imaging region of interest can be identified between infected and uninfected individuals, up to 6 individuals on suppressive ART will be administered 89Zr radiolabeled VRC01 followed by PET-MRI (Phase 2). Timing of the PET-MR scans will be determined based on the data from Phase 1.

Keywords

HIV-1-infection PET scan MRI Viremia Antiretroviral therapy Antibodies Immunoglobulins Antibodies, Monoclonal [89]Zr-DFO-VRC-HIVMAB060-00-AB Viremic HIV-infected Suppressed HIV-infected

Eligibility

You can join if…

Open to people ages 18 years and up

Study Phase 1

  1. Age ≥18 years, and
  2. HIV uninfected, or
  3. HIV infection, and
  4. has an HIV viral load measurement within 12 months of study entry of >40 copies/mL,and
  5. HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activity (HIV infected participants only)

Study Phase 2

  1. Age ≥18 years, and
  2. HIV infection, and
  3. 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), and
  4. HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activity

You CAN'T join if...

Study Phase 1

  1. For patients planning to be imaged on PET-MR scanner, exclusion criteria will include any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia
  2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
  3. Patients who have had a study involving radiation within six months of enrolling in this study
  4. 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)
  5. 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.
  6. Absolute CD4+ T cell count <100 cells/μL (HIV infected individuals only)
  7. Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months.
  8. 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

  1. For patients planning to be imaged on PET-MR scanner, exclusion criteria will include any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia
  2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
  3. Patients who have had a study involving radiation within 12 months of enrolling in this study
  4. 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)
  5. 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.
  6. Absolute CD4+ T cell count <100 cells/μL (HIV infected individuals only)
  7. Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months.
  8. Current HIV-related opportunistic infection such as pneumocystis pneumonia,disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (limited oral thrush acceptable) and cerebral toxoplasmosis

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94110 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03729752
Phase
Phase 1
Lead Scientist
Timothy Henrich
Study Type
Interventional
Last Updated