Massachusetts General Hospital: Inclusion/Exclusion Criteria

Massachusetts General Hospital
Inclusion/Exclusion Criteria

Inclusion Criteria

  • HIV negative individuals with documented HIV negative antibody and HIV RNA per screening lab tests or, if enrolled in PHRC-approved protocol #2010P002121, as per annual screening labs for that study
  • Laboratory values within 28 days prior to enrollment that meet the following criteria:
    • Hemoglobin > 10.0 g/dL
    • Absolute neutrophil count > 1000/mm3
    • Platelet count > 80,000/mm3
    • Prothrombin time (PT) < 1.5 x upper limit of normal (ULN)
    • Partial thromboplastin time (PTT) 1.5 x ULN
  • Negative urine pregnancy test (sensitive to 25 IU HCG) at screening and within 24 hours of the study procedure for female participants
  • Ability and willingness to give written informed consent and to comply with study requirements

Exclusion Criteria

  • Female subject who is pregnant or less than 8 weeks postpartum
  • Use of any immunemodulatory agents within 30 days prior to study enrollment
  • History of intolerance, sensitivity, allergy or anaphylaxis to benzodiazepines or other narcotics to be used during the procedure
  • History of intolerance, sensitivity, allergy or anaphylaxis to lidocaine or other amide anesthetics, as well as benzocaine or other ester type anesthetics
  • History of coronary artery disease, myocardial infarction, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the investigator will compromise ability to participate in the study
  • Currently taking anticoagulants including but not limited to: heparin (Hep-Lock, Hep-Pak), Hep-Pak CVC, Heparin Lock Flush), warfarin (Coumadin), tinzaparin (Innohep), enoxaparin (Lovenox), danaparoid (Orgaran), dalteparin (Fragmin), clopidogrel (Plavix), prophylactic aspirin, and regular NSAID use
  • Subject taking any of the following medications:  systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g., local injection of interferon alpha for treatment of HPV is permitted) or systemic chemotherapy
  • Prior recipient of HIV vaccine
  • Systemic antibiotic therapy within 30 days of enrollment or procedure
  • Currently employed at or affiliated with Ragon Institute of MGH, MIT, or Harvard
  • Anyone unable to lay flat on the scanner table for imaging
  • BMI > 32 because of the poor quality of images that can be obtained or weight restrictions on the scanner
  • Previously enrolled in research involving ionizing radiation of 15 mSv or more in previous year