Safety Study of Multikine in the Treatment of Perianal Warts

Condyloma Clinical Trial

Official title: Phase 1 Study of Multikine in the Treatment of Perianal Warts

Status Terminated

Clinical Trial 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

Clinical Trial Description

There are no further details to describe regarding this research project ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Condyloma

• NCT number: NCT02115919
• Study type: Interventional
• Source: United States Naval Medical Center, San Diego
• Status: Terminated
• Phase: Phase 1
• Start date: April 2014
• Completion date: January 2016