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

NCT03729752 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 17-23507
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection

Keywords

HIV-1-infection; PET scan; MRI; Viremia; Antiretroviral therapy

Outcome Measures

Primary Outcomes (2)

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

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

  120 hours

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

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

  120 hours

Secondary Outcomes (1)

• 89Zr-DFO-VRC01 uptake in aviremic HIV-infected individuals.

  72 hours

Study Arms (3)

Healthy Volunteer

ACTIVE COMPARATOR

Four serial PET-MR scans over 120 hours following a single, bolus injection of \[89\]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).

Drug: [89]Zr-DFO-VRC-HIVMAB060-00-AB

Viremic HIV-infected

EXPERIMENTAL

Four serial PET-MR scans over 120 hours following a single, bolus injection of \[89\]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).

Drug: [89]Zr-DFO-VRC-HIVMAB060-00-AB

Suppressed HIV-infected

EXPERIMENTAL

A PET-MR scan following a single, bolus injection of \[89\]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).

Drug: [89]Zr-DFO-VRC-HIVMAB060-00-AB

Interventions

[89]Zr-DFO-VRC-HIVMAB060-00-AB DRUG

Radiolabeled monoclonal antibody that targets the envelope protein of HIV-1.

Also known as: [89]Zr-DFO-VRC01

Healthy Volunteer; Suppressed HIV-infected; Viremic HIV-infected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

RECRUITING

Related Publications (1)

• Beckford-Vera DR, Flavell RR, Seo Y, Martinez-Ortiz E, Aslam M, Thanh C, Fehrman E, Pardons M, Kumar S, Deitchman AN, Ravanfar V, Schulte B, Wu IK, Pan T, Reeves JD, Nixon CC, Iyer NS, Torres L, Munter SE, Hyunh T, Petropoulos CJ, Hoh R, Franc BL, Gama L, Koup RA, Mascola JR, Chomont N, Deeks SG, VanBrocklin HF, Henrich TJ. First-in-human immunoPET imaging of HIV-1 infection using 89Zr-labeled VRC01 broadly neutralizing antibody. Nat Commun. 2022 Mar 9;13(1):1219. doi: 10.1038/s41467-022-28727-5.

  PMID: 35264559 DERIVED

MeSH Terms

Conditions

Viremia

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy Henrich, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Henrich, MD

CONTACT

4158-206-5518; timothy.henrich@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: November 1, 2018
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)