- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03729752
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
August 9, 2023 updated by: Timothy Henrich, University of California, San Francisco
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This will be a single-center pilot study to determine dosimetry and tissue uptake/distribution and pharmacokinetics of 89Zr-VRC01.
Up to 18 uninfected and HIV-infected subjects who are either taking or not taking ART will receive a small IV dose of 89Zr-VRC01.
After administration of IV 89Zr-VRC01, subjects will undergo up to 4 whole body PET/MR imaging at 2, 6, 24 and 72-120h to determine the pharmacokinetics and radiation dose exposure.
The study involves two phases with the second phase only to be performed only if a difference between PET activity in one or more region of interest can be determined between participant groups Phase I (HIV infected, viremic participants and healthy volunteers).
Initially, up to 6 individuals with plasma HIV RNA levels >1,000 copies/ml and up to 6 HIV-uninfected individuals will be administered 89Zr radiolabeled VRC01 followed by PET-MR imaging as above (Phase 1).
If differences in PET activity in one or more imaging region of interest can be identified between infected and uninfected individuals, up to 6 individuals on suppressive ART will be administered 89Zr radiolabeled VRC01 followed by PET-MRI (Phase 2).
Timing of the PET-MR scans will be determined based on the data from Phase 1.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Timothy Henrich, MD
- Phone Number: 4158-206-5518
- Email: timothy.henrich@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- Recruiting
- University of California, San Francisco
-
Contact:
- Emily Fehrman, BS
- Phone Number: 340 415-476-4082
- Email: emily.fehrman@ucsf.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Volunteer
Four serial PET-MR scans over 120 hours following a single, bolus injection of [89]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).
|
Radiolabeled monoclonal antibody that targets the envelope protein of HIV-1.
Other Names:
|
Experimental: Viremic HIV-infected
Four serial PET-MR scans over 120 hours following a single, bolus injection of [89]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).
|
Radiolabeled monoclonal antibody that targets the envelope protein of HIV-1.
Other Names:
|
Experimental: Suppressed HIV-infected
A PET-MR scan following a single, bolus injection of [89]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).
|
Radiolabeled monoclonal antibody that targets the envelope protein of HIV-1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosimetry of 89Zr-DFO-VRC01 in healthy volunteers and HIV-infected participants.
Time Frame: 120 hours
|
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.
Time Frame: 120 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
89Zr-DFO-VRC01 uptake in aviremic HIV-infected individuals.
Time Frame: 72 hours
|
To evaluate the uptake and tissue distribution of 89Zr-DFO-VRC01 in HIV-infected participants on suppressive antiretroviral therapy (ART) compared with HIV-infected, viremic individuals and healthy volunteers.
Study Phase 2.
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Timothy Henrich, MD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Estimated)
October 31, 2024
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
November 1, 2018
First Submitted That Met QC Criteria
November 1, 2018
First Posted (Actual)
November 5, 2018
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-23507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We do not plan on sharing IPD with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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