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NCT02115919 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Multikine in the Treatment of Perianal Warts
A Phase 1 study, sponsored by United States Naval Medical Center, San Diego.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02115919 is a Phase 1 study that was terminated before completion, run by United States Naval Medical Center, San Diego. The registered enrollment target is 4 participants.
The verdict
NCT02115919, a Phase 1 study, was terminated before completion, sponsored by United States Naval Medical Center, San Diego.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study 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
Interventions
- DRUG Leukocyte Interleukin, Injection 200IU
- DRUG Leukocyte Interleukin, injection 400IU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02115919
The ClinicalTrials.gov registry entry for NCT02115919 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Naval Medical Center, San Diego, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Leukocyte Interleukin, Injection 200IU is the first listed.
NCT02115919 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02115919 about?
NCT02115919 is a clinical study titled "Safety Study of Multikine in the Treatment of Perianal Warts". 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. Establis...
What is the current status of trial NCT02115919?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-04. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02115919?
The interventions under investigation include: Leukocyte Interleukin, Injection 200IU (DRUG), Leukocyte Interleukin, injection 400IU (DRUG).
Who is sponsoring clinical trial NCT02115919?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
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