Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts

Inclusion Criteria

• •1. ≥18 years of age
• •2. Diagnosed with perianal condyloma by primary clinician
• •3. HIV-infected, may be on or off of antiretroviral therapy. Enrolment of subjects on HAART will be restricted to those individuals for whom an alternative regimen can reasonably be constructed in case of failure.
• •4. Negative reaction to intradermal test with ciprofloxacin (a fluoroquinolone antibiotic)
• •5. Any CD4 count will be considered appropriate for study
• •6. Blood WBC \> 2.0x103/mm3 and absolute neutrophils count \> 500
• •7. Blood hemoglobin \> 10.0 g/dL
• •8. Blood platelet count \> 50x103/mm3
• •9. Serum total bilirubin \< 6.0 mg/dL (participants taking atazanavir-based ARV regimens may have elevated total bilirubin but are generally \< 6)
• •10. Blood aspartate aminotransferase (AST) \< 100 U/L (\<2 ULN)
• •11. Blood alanine aminotransferase (ALT) \< 130 U/L (\<2 ULN)
• •12. Serum creatinine \< 1.5 mg/dL
• •13. ECOG performance status \< 3
• •14. If a subject is of reproductive potential he/she and her/his sexual partner MUST be willing and able to utilize highly effective methods of contraception (e.g., birth control pill, barrier methods with spermicide - as applicable) for the duration of the study including the study follow-up period.
• •15. Subjects must be willing to refrain from anal sex, douching and use of enemas prior to scheduled Pap smears