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

RecruitingPhase 1Ages 18 Years - anyAllUniversity of California, San Francisco
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Study Phase 1 1. Age โ‰ฅ18 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 โ‰ฅ18 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/ฮผL (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/ฮผL (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
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What it tests

  • [89]Zr-DFO-VRC-HIVMAB060-00-AB
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Where

1 site
University of California, San Francisco
San Francisco, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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