Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts (PAW)
Perianal Warts
About this trial
This is an interventional other trial for Perianal Warts
Eligibility Criteria
Inclusion Criteria: ≥18 years of age Diagnosed with perianal condyloma by primary clinician 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. Negative reaction to intradermal test with ciprofloxacin (a fluoroquinolone antibiotic) Any CD4 count will be considered appropriate for study 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 (participants 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 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. Subjects must be willing to refrain from anal sex, douching and use of enemas prior to scheduled Pap smears Exclusion Criteria: Anal cancer (current or history of) Inability to attend study visits Participation in any other drug study History of asthma History of CHF and/or cardiac support for arrhythmia or on chronic cardiac medication or has other chronic or acute cardiac ailments (e.g., or abnormal EKG at Baseline) History of organ transplantation or requiring chronic administration of immune suppressive drugs in the last 6 months For women, neither pregnant nor lactating In the opinion of the Primary Investigator, the subject may not be able to tolerate the study treatment regimen Subjects who are currently using or have recently within past 3 months) been treated with immunomodulators (e.g., Interferon-α) Subjects with active infections including sexually transmitted diseases (e.g., N. gonorrhea, C. trachomatis, H. ducreyi, T. pallidum) History of allergic reaction to fluoroquinolone antibiotics (e.g., ciprofloxacin, ofloxacin)
Sites / Locations
- Naval Medical Center San Diego
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A
Arm B
Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks.
Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks.