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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: Clinical Trial Phase 1 study, sponsored by United States Naval Medical Center, San Diego.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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
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 |
Why NCT02115919 stopped before completion
NCT02115919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Leukocyte Interleukin, Injection 200IU is the first listed.
NCT02115919 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02115919's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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