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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03038828
Study type Interventional
Source CEL-SCI Corporation
Contact
Status Terminated
Phase Phase 1
Start date April 2015
Completion date September 2018

See also
  Status Clinical Trial Phase
Completed NCT02462187 - Topical NVN1000 for the Treatment of External Genital and Perianal Warts Phase 2
Completed NCT01082302 - Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage Phase 4