Safety Study of Multikine in the Treatment of Perianal Warts

Summary

Caused by the human papillomavirus (HPV), anogenital warts are a common sexually-transmitted infection (STI). They are distressing to those who have them and are a source of viral shedding and transmission to others. Treatment of warts is aimed at destruction of the lesion.

Objectives:

1. Establish safety of Multikine in treatment of perianal condyloma.
2. Describe presence of anal HPV and anal dysplasia in participants with perianal condyloma.
3. Describe adverse effects associated with Multikine in the management of perianal condyloma.

Design:

Phase I, dose-escalation trial. Potential participants desiring treatment for their perianal warts will be referred to study by their primary clinician. All participants will undergo baseline anal Pap, anal HPV subtyping, perianal condyloma characterization (count, measurement, photography), and complete a baseline questionnaire. Cohort A participants will undergo perilesional Multikine injections (200IU) once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days. If no serious adverse events are noted after 4 weeks of therapy, cohort B will be studied using the same schedule but with a dose of 400IU per treatment. Each participant will undergo anal Pap and anal HPV subtyping once weekly during treatment. Condyloma characterization (count, measurement, photography) will occur prior to each treatment. After treatment completed, participants will complete a follow-up visit at 70, 100, 130, 160 days and have anal Pap, anal HPV subtyping, and perianal condyloma characterization (count, measurement, photography) performed.

Subjects:

The study will be open to adult men and women who are HIV-infected who receive medical care from the Naval Medical Center San Diego.

Main Outcome Measures:

1. Perianal wart characterization \[count, measurement (in millimeters diameter)\], photography)
2. HPV subtype in anal canal
3. Anal dysplasia cytologic grade
4. Questionnaire responses
5. Adverse effects experienced during treatment, recorded in symptom log

Conditions

• Condyloma

Interventions

DRUG

Leukocyte Interleukin, Injection 200IU

Cohort A participants will receive 200IU Multikine perilesional injections once daily, Monday through Friday, for 14 days, then 14 days off with out any Multikine injections received. After the 14 days without receiving the Investigational Product injections they will begin a second round of 200IU Multikine perilesional injections once daily, Monday through Friday for 14 days.

DRUG

Leukocyte Interleukin, injection 400IU

Cohort B participants will receive 400IU Multikine perilesional injections once daily, Monday through Friday, for 14 days, then they will not receive any Multikine perilesional injections for 14 days. After the 14 day rest period when the participants did not receive the Investigational Product injections they will begin a second round of 400IU Multikine perilesional injections every day, Monday through Friday, for 14 days.

Sponsors & Collaborators

• CEL-SCI Corporation

  collaborator INDUSTRY

• United States Naval Medical Center, San Diego

  lead FED

Principal Investigators

• John D Malone, MD · NMCSD

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2016-01-31

Completion

2016-01-31

Countries

• United States

Study Locations