Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFN lozenges | Experimental | 500 IU Interferon-alpha lozenges for oral dissolution |
|
| placebo lozenges | Placebo Comparator | 200 mg lozenges containing anhydrous crystalline maltose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-alpha | Drug | 500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah Greenspan, BDS, DSc | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, School of Dentistry | San Francisco | California | 94143 | United States | ||
| Nova Southeastern University College of Dental Medicine |
All 59 enrolled subjects were randomized to treatment and took at least 1 dose of assigned study drug.
Enrollment took place between January 2007 and March 2009 at 10 university-affiliated dental clinics across the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IFN Lozenges | 500 IU Interferon-alpha lozenges for oral dissolution |
| FG001 | Placebo Lozenges | 200 mg lozenges containing anhydrous crystalline maltose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IFN Lozenges | 500 IU Interferon-alpha lozenges for oral dissolution |
| BG001 | Placebo Lozenges | 200 mg lozenges containing anhydrous crystalline maltose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Per protocol | Posted | Number | participants | 24 weeks, from baseline to the end of treatment |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IFN Lozenges | 500 IU Interferon-alpha lozenges for oral dissolution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
Only 59 of 80 planned subjects were randomized, so statistical power of the study was limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin J. Cummins | Amarillo Biosciences, Inc. | 806-376-1741 | 14 | mcummins@amarbio.com |
Not provided
| ID | Term |
|---|---|
| D010212 | Papilloma |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D014860 | Warts |
| ID | Term |
|---|---|
| D018307 | Neoplasms, Squamous Cell |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D008320 | Maltose |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Other | 200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks |
|
|
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 |
| Fort Lauderdale |
| Florida |
| 33328-2018 |
| United States |
| Medical College of Georgia School of Dentistry | Augusta | Georgia | 30912-1241 | United States |
| University of Illinois at Chicago, College of Dentistry | Chicago | Illinois | 60612 | United States |
| University of Kentucky College of Dentistry | Lexington | Kentucky | 40536-0297 | United States |
| University of Maryland Baltimore Dental School | Baltimore | Maryland | 21201 | United States |
| Division of Oral Medicine and Dentistry, Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| UMDNJ - New Jersey Dental School | Newark | New Jersey | 07108 | United States |
| New York University College of Dentistry | New York | New York | 10010 | United States |
| University of Pennsylvania School of Dental Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor College of Dentistry | Dallas | Texas | 75246 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | 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 | Per protocol - only a sub-set of subjects had lip warts at study entry | Posted | Number | participants | 24 weeks, from baseline to the end of treatment |
|
|
|
|
| Secondary | 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." | Posted | Number | participants | 24 weeks, from baseline to the end of treatment |
|
|
|
|
| Secondary | 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." | Posted | Number | participants | 24 weeks, from baseline to end of treatment |
|
|
|
|
| Secondary | 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." | Posted | Number | participants | 24 weeks, from baseline to the end of treatment |
|
|
|
|
| Secondary | 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." | Posted | Number | participants | 24 weeks, from baseline to the end of treatment |
|
|
|
|
| 3 |
| 45 |
| 7 |
| 45 |
| EG001 | Placebo Lozenges | 200 mg lozenges containing anhydrous crystalline maltose | 1 | 14 | 3 | 14 |
| anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| esophageal ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| tooth extraction | Surgical and medical procedures | Non-systematic Assessment |
|
| candidiasis | Infections and infestations | Non-systematic Assessment |
|
| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |