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

Eligibility Criteria

• 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)
• 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
• 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
• 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