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