Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts

Study Overview
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Brief Summary
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Study is a dose escalation study. 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 again 5 days/week for 2 weeks. If no serious adverse events are noted in cohort A patients, ten participants will be treated in cohort B. Cohort B participants will be treated the same as cohort A participants except that dose will be increased to 400IU Multikine per day.

Detailed Description
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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.

Official Title
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Phase 1 Dose Escalation Study to Establish the Safety of Leukocyte Interleukin, Injection for Treatment of Perianal Warts in Adult Men and Women Who Are HIV/HPV Co-infected

Conditions
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Perianal Warts

Intervention / Treatment
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* Biological: Leukocyte Interleukin, Injection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks. | Biological: Leukocyte Interleukin, Injection<br>* Immunotherapy<br>* Other names: Multikine;|
| Experimental: Arm B<br>Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks. | Biological: Leukocyte Interleukin, Injection<br>* Immunotherapy<br>* Other names: Multikine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wart characterization change | Perianal wart characterization includes counting the number of identified warts, the diameter measurement of each identified wart in millimeters and the photographic imaging of each identified wart during the treatment phase and the follow-up phase of the study | Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of HPV subtype identification change | HPV subtyping will be performed on specimens collected from the anal canal. | Days 0, 4, 11, 32, 39, 70, 100 130, 160 | 
| Assessment of Anal dysplasia cytologic grade change | Anal dysplasia cytologic specimen collection will take place during the treatment phase and the follow-up phase of the study | Days 0, 4, 11, 32, 39, 70, 100, 130, 160 | 
| Assessment of adverse effects during the treatment phase of the study assessed | Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log | Days 0, 4, 11, 32, 39, 70, 100, 130, 160 |