PET Imaging with VRC01 for HIV

Overseen By Timothy Henrich, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Francisco

Must be taking: Combination ART

Disqualifiers: Pregnancy, Opportunistic infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Timothy Henrich, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over 18, both HIV-infected with specific viral characteristics and healthy volunteers. HIV participants should either have a detectable viral load or be on ART with an undetectable viral load. Exclusions include pregnancy, certain medical conditions, metal implants incompatible with MRI, recent radiation studies, low blood counts or organ function tests.

Inclusion Criteria

I am over 18, may have HIV with undetectable viral load or detectable HIV, or I do not have HIV.

Exclusion Criteria

Study Phase 2: Patients planning to be imaged on PET-MR scanner with contra-indications to MRI, any medical condition compromising imaging acquisition, recent radiation study, pregnancy, specific blood count and liver enzyme levels, low CD4+ T cell count, recent serious illness, current HIV-related opportunistic infections

Study Phase 1: Patients planning to be imaged on PET-MR scanner with contra-indications to MRI, any medical condition compromising imaging acquisition, recent radiation study, pregnancy, specific blood count and liver enzyme levels, low CD4+ T cell count, recent serious illness, current HIV-related opportunistic infections

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Imaging

Participants receive a single intravenous microdose of 89Zr-DFO-VRC01 followed by up to 4 whole-body PET-MR imaging sessions to determine dosimetry and tissue uptake/distribution.

120 hours

4 visits (in-person)

Phase 2 Imaging

If differences in PET activity are identified, additional participants on suppressive ART will receive 89Zr-DFO-VRC01 followed by PET-MR imaging.

72 hours

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging sessions

4 weeks

Treatment Details

Interventions

• 89Zr-DFO-VRC-HIVMAB060-00-AB

Trial Overview The study involves one dose of a radiolabeled antibody (89Zr-DFO-VRC01) given intravenously followed by PET-MR imaging to track its distribution in the body. This exploratory study aims to understand how the antibody travels and accumulates in tissues over time but does not treat HIV directly.

Participant Groups

Group I: Viremic HIV-infected Experimental Treatment 1 Intervention

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

Group II: Suppressed HIV-infected Experimental Treatment 1 Intervention

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

Group III: Healthy Volunteer Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

amfAR, The Foundation for AIDS Research

Collaborator

Trials

29

Recruited

6,200+