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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
8
Immunotherapy
Naval Medical Center San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
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: Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
Assessment of HPV subtype identification change
HPV subtyping will be performed on specimens collected from the anal canal.
Time frame: 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
Time frame: 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
Time frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
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