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Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts (PAW)

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ClinicalTrials.gov Identifier: NCT03038828
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : February 1, 2017
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
Ergomed Clinical Research Inc.
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
CEL-SCI Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Perianal Warts Biological: Leukocyte Interleukin, Injection Phase 1

Detailed 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : April 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: Arm A
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
Immunotherapy
Other Name: Multikine

Experimental: Arm B
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
Immunotherapy
Other Name: Multikine




Primary Outcome Measures :
  1. Wart characterization change [ Time Frame: Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ] ]
    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


Secondary Outcome Measures :
  1. Assessment of HPV subtype identification change [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100 130, 160 ]
    HPV subtyping will be performed on specimens collected from the anal canal.

  2. Assessment of Anal dysplasia cytologic grade change [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
    Anal dysplasia cytologic specimen collection will take place during the treatment phase and the follow-up phase of the study

  3. Assessment of adverse effects during the treatment phase of the study assessed [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
    Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038828


Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134-5000
University of California San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
CEL-SCI Corporation
Ergomed Clinical Research Inc.
United States Naval Medical Center, San Diego
Investigators
Study Director: Eyal Talor, PhD CEL-SCI Chief Scientific Officer

Responsible Party: CEL-SCI Corporation
ClinicalTrials.gov Identifier: NCT03038828     History of Changes
Other Study ID Numbers: NMCSD2013.008_UCSF
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases