Eligibility Details:
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
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
