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RecruitingAccepts healthy volunteersPhase 1

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

University of California, San Francisco · with amfAR, The Foundation for AIDS Research · NCT03729752

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
30
US sites recruiting
1
Study start
November 1, 2018
Record last updated
June 5, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: [89]Zr-DFO-VRC-HIVMAB060-00-AB

Conditions: HIV-1-infection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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 Criteria

Study Phase 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
  • 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

  • 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
  • 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

Recruiting US locations

  • University of California, San Francisco

    San Francisco, CA 94110

    Site contact: Emily Fehrman, BS · 415-476-4082 · emily.fehrman@ucsf.edu

Study contacts (from the official record)

  • Timothy Henrich, MD · 4158-206-5518 · timothy.henrich@ucsf.edu
All healthy volunteers studies in California →
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal… (NCT03729752) | Bored Studies