Clinical trial NCT03038828: Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Perianal Warts
Lead sponsor: CEL-SCI Corporation
Sponsor class: INDUSTRY
Collaborators: name: Ergomed Clinical Research Inc.
name: United States Naval Medical Center, San Diego
First posted: 2017-02-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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.

Eligibility 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)

Primary outcomes:
measure: Wart characterization change
timeFrame: Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
Secondary outcomes:
measure: Assessment of HPV subtype identification change
timeFrame: Days 0, 4, 11, 32, 39, 70, 100 130, 160
measure: Assessment of Anal dysplasia cytologic grade change
timeFrame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
measure: Assessment of adverse effects during the treatment phase of the study assessed
timeFrame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: CEL-SCI Chief Scientific Officer
name: Eyal Talor, PhD
role: STUDY_DIRECTOR
References: