NCT03729752 PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
| NCT ID | NCT03729752 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, San Francisco |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2018-11-01 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2018-11-01 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Study Phase 1 1. Age ≥18 years, and 2. HIV uninfected, or 3. HIV infection, and 4. has an HIV viral load measurement within 12 months of study entry of \>40 copies/mL, and 5. HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activity (HIV infected participants only) Study Phase 2 1. Age ≥18 years, and 2. HIV infection, and 3. 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 4. HIV infection, and 5. has an HIV viral load measurement within 12 months of study entry of \>40 copies/mL, and 6. HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activity, or 7. HIV uninfected Exclusion Criteria: Study Phase 1 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 2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator 3. Patients who have had a study involving radiation within six months of enrolling in this study 4. 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) 5. 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. 6. Absolute CD4+ T cell count \<100 cells/μL (HIV infected individuals only) 7. Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months. 8. 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 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 2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator 3. Patients who have had a study involving radiation within 12 months of enrolling in this study 4. 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) 5. 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. 6. Absolute CD4+ T cell count \<100 cells/μL (HIV infected individuals only) 7. Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months. 8. Current HIV-related opportunistic infection such as pneumocystis pneumonia, disseminated microbacterial infection, invasive cryptococcal disease, candidal esophagitis (limited oral thrush acceptable) and cerebral toxoplasmosis
Contact & Investigator
Timothy Henrich, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT03729752 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03729752 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03729752 currently recruiting?
Yes, NCT03729752 is actively recruiting participants. Contact the research team at timothy.henrich@ucsf.edu for enrollment information.
Where is the NCT03729752 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT03729752 clinical trial?
NCT03729752 is sponsored by University of California, San Francisco. The principal investigator is Timothy Henrich, MD at University of California, San Francisco. The trial plans to enroll 30 participants.
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