Treatment of Oral Warts in HIV+ Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Papillomatosis, HIV Infections

Intervention / Treatment
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* Drug: Interferon-alpha
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human immunodeficiency virus, human papilloma virus, warts, oral, papillomatosis, treatment experienced