Clinical trial NCT02115919: Safety Study of Multikine in the Treatment of Perianal Warts
Official title: Phase 1 Study of Multikine in the Treatment of Perianal Warts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Condyloma
Keywords: condyloma
HIV
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: CEL-SCI Corporation
First posted: 2014-04-16
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: There are no further details to describe regarding this research project

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Diagnosed with perianal condyloma by primary clinician
* HIV-infected, may be on or off of antiretroviral therapy
* any CD4 count will be considered appropriate for study
* Blood WBC \> 2.0x103/mm3 and absolute neutrophils count \> 500
* Blood hemoglobin \> 10.0 g/dL
* Blood platelet count \> 50x103/mm3
* Serum total bilirubin \< 6.0 mg/dL (participants taking atazanavir-based ARV regimens may have elevated total bilirubin but are generally \< 6)
* Blood aspartate aminotransferase (AST) \< 100 U/L (\<2 ULN)
* Blood alanine aminotransferase (ALT) \< 130 U/L (\<2 ULN)
* Serum creatinine \< 1.5 mg/dL
* ECOG performance status \< 3
* If a subject is of reproductive potential he/she and her/his sexual partner MUST be willing and able to utilize 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.

Exclusion Criteria:

* Anal cancer (current or history of)
* Inability to attend study visits
* Participation in any other drug study
* History of asthma
* History of organ transplantation or requiring chronic administration of immune suppressive drugs in the last 6 months
* For women, neither pregnant nor lactating
* In the opinion of the PI, the subject may not be able to tolerate the study treatment regimen

Primary outcomes:
measure: Wart characterization change is being assessed
timeFrame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Secondary outcomes:
measure: HPV subtype identification change is being assessed
timeFrame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
measure: Anal dysplasia cytologic grade change is being assessed
timeFrame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
measure: Adverse effects during the treatment phase of the study are being assessed
timeFrame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Other outcomes:
Locations:
city: San Diego
country: United States
facility: NMCSD
state: California
Study officials:
affiliation: NMCSD
name: John D Malone, MD
role: PRINCIPAL_INVESTIGATOR
References: