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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special imaging technique maps the movement of 89Zr-DFO-VRC01, an experimental imaging agent, in the body. While not a treatment for HIV, it helps researchers observe the substance's movement in individuals with and without the virus. The trial includes different groups: those with HIV with controlled and uncontrolled virus levels, and healthy volunteers. Individuals living with HIV who have recent viral load measurements might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging method is safe?

Research has shown that VRC01, a lab-made protein, has been studied for safety in people. In past studies, it was generally well-tolerated, with no major safety concerns. Most side effects were mild, such as slight reactions at the injection site or mild flu-like symptoms.

In this trial, a small, safe amount of a radioactive tracer called 89Zr is attached to VRC01 to aid in imaging. The small dose is designed to minimize any risk. As this trial is in an early phase, it primarily assesses safety and how the treatment functions in the body.

Prospective participants should note that early trials focus on ensuring safety, and this one has shown no serious problems in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PET Imaging with VRC01 for HIV trial because it's exploring a novel way to visualize and understand HIV in the body. Unlike traditional treatments that focus on suppressing the virus with antiretroviral drugs, this method uses a radioactive antibody, 89Zr-DFO-VRC01, to highlight HIV-infected cells during PET-MR scans. This could provide deeper insights into where the virus hides and how it persists, potentially leading to more targeted and effective treatments in the future. By mapping the virus's locations, researchers hope to crack open new pathways for tackling HIV that go beyond just keeping it in check with existing medications.

What evidence suggests that this imaging method is effective for studying HIV?

Research has shown that 89Zr-DFO-VRC01 is under study to locate where HIV hides in the body. This trial uses a special imaging technique called immunoPET to highlight areas where HIV remains active. Participants will be divided into groups, including those with suppressed HIV, viremic HIV, and healthy volunteers, to assess this method's effectiveness. Early results suggest promise in identifying hidden HIV spots. Although this is not a direct treatment to cure or reduce HIV, it may enhance understanding of the virus. This knowledge could lead to improved HIV management in the future. ^{2 5 6 7 8}

Who Is on the Research Team?

Timothy Henrich, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35264559/

First-in-human immunoPET imaging of HIV-1 infection using ... We assess the efficacy of using immunoPET imaging to characterize HIV reservoirs and identify anatomical foci of persistent viral transcriptional activity.

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT03729752

UCSF HIV/AIDS Trial → PET Imaging of Radiolabeled Anti ... 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03729752?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(vrc01)))&rank=5

PET Imaging of Radiolabeled Anti-HIV-1 Envelope ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/417536

PET Imaging of Radiolabeled Anti-HIV-1 Envelope ... This is a single center exploratory imaging study involving one intravenous microdose of 89Zr-DFO-VRC01 followed by whole-body PET-MR ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8907355/

First-in-human immunoPET imaging of HIV-1 infection ... First-in-human immunoPET imaging of HIV-1 infection using 89 Zr-labeled VRC01 broadly neutralizing antibody

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02591420?term=AREA%5BIdSearch%5D(%22NCT02140255%22OR%22NCT02165267%22OR%22NCT02256631%22OR%22NCT02411539%22OR%22NCT02463227%22OR%22NCT02471326%22OR%22NCT02568215%22OR%22NCT02591420%22OR%22NCT02599896%22OR%22NCT02664415%22OR%22NCT02716675%22OR%22NCT02797171%22OR%22NCT03036709%22OR%22NCT03208231%22OR%22NCT03831945%22)&rank=7

Safety and Virologic Effect of a Human Monoclonal ... Human monoclonal antibodies (mAbs) may have the potential to treat HIV infection by preventing the spread of the virus. This study will evaluate an ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4636891/

Safety, pharmacokinetics and neutralization of the broadly ... VRC-HIVMAB060-00-AB (VRC01) is a broadly neutralizing HIV-1 monoclonal antibody (mAb) isolated from the B cells of an HIV-infected patient.

8. withpower.com withpower.com/trial/phase-1-infections-10-2018-6f0a3

PET Imaging with VRC01 for HIV 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 ...