Imaging Immune Activation in HIV by PET-MR

The PET radiofluorinated imaging agent, [18F]F-AraG
(2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine; trade name VisAcT) localizes to sites of
immune activation and is predominantly accumulated in proliferative T cells. As a result,
there is interest in imaging residual immune activation in the setting of both treated and
untreated HIV-1 infection, a disease in which chronic immune activation and inflammation may
lead to significant morbidity, despite the use of otherwise suppressive ART.

The primary endpoint is to determine the anatomical distribution of [18F]F-AraG in
HIV-infected individuals taking or not taking antiretroviral therapy.

Secondary objectives are to determine if [18F]F-AraG PET-MRI is able to detect differences in
T cell activation between patients with early versus late treated HIV infection and to
determine if [18F]F-AraG uptake correlates with direct blood and tissue measures of HIV
reservoir size and activity in the above cohorts/studies.

Inclusion Criteria:

1. Age >18 years

2. Ability to read and understand written informed consent document

3. HIV infection, and Initiated a combination ART regimen, or, has never received ART,
or, has received ART in the past, but has not been taking for a least 1 month prior to
enrollment

Exclusion Criteria:

1. 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 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)

4. Patients who are breastfeeding

5. Patients who have had prior allogeneic stem cell or solid organ transplant

6. 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.

7. Absolute CD4+ T cell count <100 cells/μL (HIV infected individuals only)

8. Serious illness requiring hospitalization or parental antibiotics within the preceding
3 months

9. Current HIV-related opportunistic infection such as pneumocystis pneumonia,
disseminated microbacterial infection, invasive cryptococcal disease, candidal
esophagitis (limited oral thrush acceptable) and cerebral toxoplasmosis

10. Previously diagnosed myelodysplasia syndrome. or history of lymphoproliferative
disease prior to study entry

11. History of congestive heart failure as defined by physician documentation in the
medical record at any time prior to screening that required medication for heart
failure or that required medical management within 1 year prior to study entry

12. Vaccination within 14 days of study entry