Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts

Study is a dose escalation study to determine the safety of Leukocyte Interleukin, Injection
in treating men and women with perianal warts who are HIV/HPV co-infected. Fifteen patients
will be enrolled in 2 treatment cohorts. Five participants (cohort A) will be treated with
200IU Multikine daily, 5 days/week for 2 weeks, off 2 weeks, then treated again 5 days/week
for 2 weeks. If no serious adverse events are noted in cohort A patients, ten (10)
participants will be treated in cohort B. Cohort B participants will be treated in the same
manner as cohort A participants except that the dose will be increased to 400IU Multikine per
day.

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

Exclusion Criteria:

1. Anal cancer (current or history of)

2. Inability to attend study visits

3. Participation in any other drug study

4. History of asthma

5. 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)

6. History of organ transplantation or requiring chronic administration of immune
suppressive drugs in the last 6 months

7. For women, neither pregnant nor lactating

8. In the opinion of the Primary Investigator, the subject may not be able to tolerate
the study treatment regimen

9. Subjects who are currently using or have recently within past 3 months) been treated
with immunomodulators (e.g., Interferon-α)

10. Subjects with active infections including sexually transmitted diseases (e.g., N.
gonorrhea, C. trachomatis, H. ducreyi, T. pallidum)

11. History of allergic reaction to fluoroquinolone antibiotics (e.g., ciprofloxacin,
ofloxacin)