Safety Study of Multikine in the Treatment of Perianal Warts

NCT02115919 | Terminated Phase 1

• 1 other identifier: NMCSD.2013.0080
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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. 1.Establish safety of Multikine in treatment of perianal condyloma.
2. 2.Describe presence of anal HPV and anal dysplasia in participants with perianal condyloma.
3. 3.Describe adverse effects associated with Multikine in the management of perianal condyloma.
4. 4.Perianal wart characterization \[count, measurement (in millimeters diameter)\], photography)
5. 5.HPV subtype in anal canal
6. 6.Anal dysplasia cytologic grade
7. 7.Questionnaire responses
8. 8.Adverse effects experienced during treatment, recorded in symptom log

Conditions

Condyloma

Keywords

condyloma; HIV

Outcome Measures

Primary Outcomes (1)

• Wart characterization change is being assessed

  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

  Days 0, 4, 11, 32, 39, 70, 100, 130, 160

Secondary Outcomes (3)

• HPV subtype identification change is being assessed

  Days 0, 4, 11, 32, 39, 70, 100, 130, 160

• Anal dysplasia cytologic grade change is being assessed

  Days 0, 4, 11, 32, 39, 70, 100, 130, 160

• Adverse effects during the treatment phase of the study are being assessed

  Days 0, 4, 11, 32, 39, 70, 100, 130, 160

Study Arms (2)

Cohort A

EXPERIMENTAL

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.

Drug: Leukocyte Interleukin, Injection 200IU

Cohort B

EXPERIMENTAL

Cohort B participants will undergo perilesional Multikine injections 400IU once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days.

Drug: Leukocyte Interleukin, injection 400IU

Interventions

Leukocyte Interleukin, Injection 200IU DRUG

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.

Also known as: Multikine, Injection 200IU

Cohort A

Leukocyte Interleukin, injection 400IU DRUG

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.

Also known as: Multikine, Injection 400IU

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• CEL-SCI Corporation: collaborator

Study Sites (1)

NMCSD

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Injections

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• John D Malone, MD

  NMCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)