Treatment of Oral Warts in HIV+ Patients

Evaluation of Natural Human Interferon Alpha Administered Oromucosally in the Treatment of Oral Warts in HIV-seropositive Subjects Receiving Combination Anti-retroviral Therapy: A Phase 2 Clinical Trial

This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in HIV-positive adults.

The hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete remission of their oral warts compared to subjects given placebo.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Papillomatosis
• Intervention / Treatment: Drug: Interferon-alpha; Other: placebo

Detailed Description

Human papilloma virus (HPV) can cause warts to form in the mouth of infected patients, particularly those with reduced immunity such as people infected with HIV. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges, can reduce or eliminate these warts in HIV+ subjects who are receiving combination anti-retroviral therapy (HAART). All potential subjects will have their warts examined and measured at a screening visit. A small amount of one wart (i.e. a biopsy) will be removed for microscopic evaluation to confirm HPV infection and a small amount of blood will be collected for testing. Subjects that qualify for entry will return for a baseline visit at which they will be randomized to active or placebo treatment for 24 weeks. Three out of four subjects will receive active treatment in this study. Subjects must return to the clinic every 6 weeks during treatment to have their warts re-examined. At these follow-up visits, subjects will be asked to complete a brief questionnaire regarding any perceived changes in their warts and their overall mouth condition. A small amount of blood will be taken at the final study visit at week 24 to assess the safety of the interferon lozenges.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, School of Dentistry
  • Florida
    • Fort Lauderdale, Florida, United States, 33328-2018
      • Nova Southeastern University College of Dental Medicine
  • Georgia
    • Augusta, Georgia, United States, 30912-1241
      • Medical College of Georgia School of Dentistry
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago, College of Dentistry
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0297
      • University of Kentucky College of Dentistry
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Baltimore Dental School
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Division of Oral Medicine and Dentistry, Brigham and Women's Hospital
  • New Jersey
    • Newark, New Jersey, United States, 07108
      • UMDNJ - New Jersey Dental School
  • New York
    • New York, New York, United States, 10010
      • New York University College of Dentistry
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania School of Dental Medicine
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor College of Dentistry
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must have tested positive for HIV.
• Must have two or more warts inside the mouth.
• Must be receiving a standard course of anti-retroviral therapy (HAART).

Exclusion Criteria:

• Must not be receiving oral or injected steroids.
• Must not be taking other drugs for treatment of oral warts.
• Must not have other active HIV-related opportunistic infections.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IFN lozenges; 500 IU Interferon-alpha lozenges for oral dissolution	Drug: Interferon-alpha; 500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks; Other Names: IFN-alpha lozenge; Veldona; low dose IFN lozenge
Placebo Comparator: placebo lozenges; 200 mg lozenges containing anhydrous crystalline maltose	Other: placebo; 200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks; Other Names: sugar pill; maltose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Oral Mucosal Area Covered by Warts.	Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area	24 weeks, from baseline to the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Surface Area of the Lips Covered by Warts	Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area	24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Changes in Warts	Number of subjects reporting change in oral warts from baseline to week 24 as "better." Scale was subjective with 3 choices: "better," "worse," or "unchanged."	24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Global Oral Changes	Number of subjects reporting change in global oral health from baseline to week 24 as "better." Scale was subjective with 3 choices: "better," "worse," or "unchanged."	24 weeks, from baseline to end of treatment
Investigator Assessment Regarding Changes in Warts	Number of subjects with improvement in oral warts from baseline to week 24 as rated by the attending investigator. Scale was subjective with 3 choices: "improved," "worsened," or "unchanged."	24 weeks, from baseline to the end of treatment
Investigator Assessment Regarding Global Oral Changes.	Number of subjects with improvement from baseline to week 24 in global oral health as rated by the attending investigator. Scale was subjective with 3 choices: "improved," "worsened," or "unchanged."	24 weeks, from baseline to the end of treatment

Collaborators and Investigators

• Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
• Investigators: Principal Investigator: Deborah Greenspan, BDS, DSc, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: March 29, 2007
• First Submitted That Met QC Criteria: March 29, 2007
• First Posted (Estimate): March 30, 2007

Study Record Updates

• Last Update Posted (Estimate): September 16, 2011
• Last Update Submitted That Met QC Criteria: September 12, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: treatment experienced; human papilloma virus; human immunodeficiency virus; warts, oral; papillomatosis
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha
• Other Study ID Numbers: 03HUHI19