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PET Imaging with VRC01 for HIV

Q: Is the FDA sanctioned to use Viremic HIV-infected treatments?

<p>Evaluating the safety of Viremic <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-infected participants on a scale from 1 to 3, our team at Power estimates it to be a 1 due to the fact that this is an early Phase I trial with little data validating its efficacy or security.</p>

Phase 1

Recruiting

Led By Timothy Henrich, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 hours

Awards & highlights

Study Summary

This trial studies imaging of a chemical in both HIV-positive people and healthy people to understand how it is taken up and distributed in the body.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is an imaging study using a microdose of the labeled antibody for tracking purposes rather than treatment, significant side effects are not expected. However, typical risks may include allergic reactions to the tracer or discomfort from the imaging process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Viremic HIV-infectedExperimental Treatment1 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-infectedExperimental Treatment1 Intervention

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

Group III: Healthy VolunteerActive Control1 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).

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,545 Total Patients Enrolled

amfAR, The Foundation for AIDS ResearchOTHER

27 Previous Clinical Trials

5,987 Total Patients Enrolled

Timothy Henrich, MDPrincipal Investigator - University of California, San Francisco

San Francisco General Hospital, University of California SFGH Medical Group

Yale University School Of Medicine (Medical School)

Brigham & Women'S Hospital (Residency)

3 Previous Clinical Trials

92 Total Patients Enrolled

Media Library

Suppressed HIV-infected Clinical Trial Eligibility Overview. Trial Name: NCT03729752 — Phase 1

HIV Research Study Groups: Suppressed HIV-infected, Healthy Volunteer, Viremic HIV-infected

HIV Clinical Trial 2023: Suppressed HIV-infected Highlights & Side Effects. Trial Name: NCT03729752 — Phase 1

Suppressed HIV-infected 2023 Treatment Timeline for Medical Study. Trial Name: NCT03729752 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for participants in this clinical research?

"According to clinicaltrials.gov, recruitment is underway for this research study which was initially posted on November 1st 2018 and most recently updated on August 9th 2023."

Answered by AI

How many individuals are taking part in this experiment?

"Confirmed. The information on clinicaltrials.gov shows that this medical study, which first appeared online in November of 2018, is actively seeking participants. 30 individuals are necessary to be recruited from one centre for the trial's completion."

Answered by AI

Is the FDA sanctioned to use Viremic HIV-infected treatments?

"Evaluating the safety of Viremic HIV-infected participants on a scale from 1 to 3, our team at Power estimates it to be a 1 due to the fact that this is an early Phase I trial with little data validating its efficacy or security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Timothy Henrich 2018. "PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03729752.