28:I[164923,["/_next/static/immutable/chunks/0x-9rc1bm-510.js","/_next/static/immutable/chunks/0u73ovrok9bmr.js","/_next/static/immutable/chunks/3t9ifrnugpnlb.js","/_next/static/immutable/chunks/3gdp0tzp2t65u.js","/_next/static/immutable/chunks/0qexc5596g7lf.js","/_next/static/immutable/chunks/3nkl8euu6dycn.js","/_next/static/immutable/chunks/28p3k9kvs3dfa.js","/_next/static/immutable/chunks/04j_o97cgxn2x.js","/_next/static/immutable/chunks/18bybpoq919w1.js"],"ClinicalTrialDetail"] 29:T4d9,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 1.2a:Td87,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 toxoplasmosis26:["$","$L28",null,{"trial":{"nctId":"NCT03729752","briefTitle":"PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)","officialTitle":"PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)","briefSummary":"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.","detailedDescription":"$29","overallStatus":"RECRUITING","phase":"PHASE1","studyType":"INTERVENTIONAL","conditions":["HIV-1-infection"],"interventions":[{"type":"DRUG","name":"[89]Zr-DFO-VRC-HIVMAB060-00-AB","description":"Radiolabeled monoclonal antibody that targets the envelope protein of HIV-1."}],"keywords":["HIV-1-infection","PET scan","MRI","Viremia","Antiretroviral therapy"],"locations":[{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","zip":"94110","lat":37.77493,"lng":-122.41942}],"eligibilityCriteria":"$2a","minAge":18,"maxAge":null,"sex":"ALL","healthyVolunteers":true,"leadSponsor":"University of California, San Francisco","collaborators":["amfAR, The Foundation for AIDS Research"],"contacts":[{"name":"Timothy Henrich, MD","role":"CONTACT","phone":"4158-206-5518","email":"timothy.henrich@ucsf.edu"}],"startDate":"$D2018-11-01T00:00:00.000Z","completionDate":"$D2026-12-01T00:00:00.000Z","primaryCompletionDate":"$D2026-10-31T00:00:00.000Z","firstPostDate":"$D2018-11-05T00:00:00.000Z","lastUpdatePostDate":"$D2025-06-05T00:00:00.000Z","enrollmentCount":30,"enrollmentType":"ESTIMATED","aiSummary":"$undefined","aiSummaryGeneratedAt":null,"id":"$undefined","createdAt":"$undefined","updatedAt":"$undefined"}}]

What this study is about