Treatment of Oral Warts in HIV+ Patients

Phase 2

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
IFN lozenges	Interferon-alpha	500 IU Interferon-alpha lozenges for oral dissolution
placebo lozenges	placebo	200 mg lozenges containing anhydrous crystalline maltose

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total Surface Area of the Lips Covered by Warts	24 weeks, from baseline to the end of treatment	Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area
Subject Questionnaire Regarding Changes in Warts	24 weeks, from baseline to the end of treatment	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."
Subject Questionnaire Regarding Global Oral Changes	24 weeks, from baseline to end of treatment	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."
Investigator Assessment Regarding Changes in Warts	24 weeks, from baseline to the end of treatment	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."
Investigator Assessment Regarding Global Oral Changes.	24 weeks, from baseline to the end of treatment	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."

Locations (12): Division of Oral Medicine and Dentistry, Brigham and Women's Hospital
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Boston, Massachusetts, United States
University of Pennsylvania School of Dental Medicine
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Philadelphia, Pennsylvania, United States
Medical College of Georgia School of Dentistry
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Augusta, Georgia, United States
UMDNJ - New Jersey Dental School
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Newark, New Jersey, United States
University of California, School of Dentistry
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San Francisco, California, United States
Baylor College of Dentistry
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Dallas, Texas, United States
University of Maryland Baltimore Dental School
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Baltimore, Maryland, United States
New York University College of Dentistry
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New York, New York, United States
Nova Southeastern University College of Dental Medicine
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Fort Lauderdale, Florida, United States
University of Illinois at Chicago, College of Dentistry
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Chicago, Illinois, United States
University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States
University of Kentucky College of Dentistry
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Lexington, Kentucky, United States