Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV

Inclusion Criteria:

- Male gender, ≥18 years of age

- HIV-infected and taking ARVs with suppressed HIV VL (<48 copies/mL) on 2 consecutive
measurements within the previous 6 months

- Any CD4 count will be considered appropriate for study

- Plasma INR < 1.5

- Plasma partial thromboplastin time (PTT) < 35s

- Blood WBC > 2.0x103/mm3 and absolute neutrophils count > 500

- Blood hemoglobin > 10.0 g/dL

- Blood platelet count > 50x103/mm3

- Serum total bilirubin < 6.0 mg/dL (subjects taking atazanavir-based ARV regimens may
have elevated total bilirubin but are generally < 6)

- Blood aspartate aminotransferase (AST) < 100 U/L (<2 ULN)

- Blood alanine aminotransferase (ALT) < 130 U/L (<2 ULN)

- Serum creatinine < 1.5 mg/dL

- ECOG performance status < 3

- Tricare beneficiary

Exclusion Criteria:

- History of AIN

- Anal canal condyloma requiring surgical treatment

- Anal cancer (current or history of)

- History of prior anal surgery, including hyfrecation, excision, cryotherapy,
photocoagulation

- Use of anticoagulants (warfarin, heparin, Pradaxa)

- Inability to attend study visits

- Participation in any other drug study