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Interferons

Interferon-alpha

Anti-Retroviral Agents

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Immunologic Factors

500 IU Interferon-alpha lozenges for oral dissolution

200 mg lozenges containing anhydrous crystalline maltose

500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks

200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks

placebo

Deborah Greenspan, BDS, DSc

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.

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.

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

Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area

Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area

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."

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."

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."

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."

Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

IFN Lozenges

Placebo Lozenges

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Only 59 of 80 planned subjects were randomized, so statistical power of the study was limited.

Martin J. Cummins

Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response.

Change in Total Oral Mucosal Area Covered by Warts.

Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response

Per protocol - only a sub-set of subjects had lip warts at study entry

Total Surface Area of the Lips Covered by Warts

Chi-square analysis of the proportion of subjects in each group reporting change in oral warts from baseline to week 24 as "better."

Subject Questionnaire Regarding Changes in Warts

Chi-square analysis of the proportion of subjects in each group reporting change in global oral health from baseline to week 24 as "better."

Subject Questionnaire Regarding Global Oral Changes

Chi-square analysis of the proportion of subjects rated as "improved" with respect to changes in oral warts from baseline to week 24 by the attending investigator.

Investigator Assessment Regarding Changes in Warts

Chi-square analysis of the proportion of subjects rated as "improved" with resepect to changes from baseline to week 24 in global oral health by the attending investigator.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment of Oral Warts in HIV+ Patients	NCT00454181	Papillomatosis HIV Infections	Interferon-alph... placebo	18 Years -	Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Treatment of Oral Warts in HIV+ Patients	NCT00454181	Papillomatosis HIV Infections	Interferon-alph... placebo	18 Years -	Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

Spots Global Cancer Trial Database for warts, oral

Every month we try and update this database with for warts, oral cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for warts, oral

Every month we try and update this database with for warts, oral cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for warts, oral cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.