Treatment of Oral Warts in HIV+ Patients
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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.
Condition | Intervention | Phase |
---|---|---|
Papillomatosis HIV Infections |
Drug: Interferon-alpha Other: placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | 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 |
- Change in Total Oral Mucosal Area Covered by Warts. [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area
- Total Surface Area of the Lips Covered by Warts [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 24 weeks, from baseline to end of treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]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. [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]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."
Enrollment: | 59 |
Study Start Date: | February 2007 |
Study Completion Date: | October 2009 |
Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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:
|
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:
|
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
![](https://webarchive.library.unt.edu/web/20130228141045im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, California | |
University of California, School of Dentistry | |
San Francisco, California, United States, 94143 | |
United States, Florida | |
Nova Southeastern University College of Dental Medicine | |
Fort Lauderdale, Florida, United States, 33328-2018 | |
United States, Georgia | |
Medical College of Georgia School of Dentistry | |
Augusta, Georgia, United States, 30912-1241 | |
United States, Illinois | |
University of Illinois at Chicago, College of Dentistry | |
Chicago, Illinois, United States, 60612 | |
United States, Kentucky | |
University of Kentucky College of Dentistry | |
Lexington, Kentucky, United States, 40536-0297 | |
United States, Maryland | |
University of Maryland Baltimore Dental School | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Division of Oral Medicine and Dentistry, Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, New Jersey | |
UMDNJ - New Jersey Dental School | |
Newark, New Jersey, United States, 07108 | |
United States, New York | |
New York University College of Dentistry | |
New York, New York, United States, 10010 | |
United States, Pennsylvania | |
University of Pennsylvania School of Dental Medicine | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Baylor College of Dentistry | |
Dallas, Texas, United States, 75246 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229-3900 |
Principal Investigator: | Deborah Greenspan, BDS, DSc | University of California, San Francisco |
![](https://webarchive.library.unt.edu/web/20130228141045im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Amarillo Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00454181 History of Changes |
Other Study ID Numbers: | 03HUHI19 |
Study First Received: | March 29, 2007 |
Results First Received: | November 9, 2010 |
Last Updated: | September 12, 2011 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amarillo Biosciences, Inc.:
human immunodeficiency virus human papilloma virus warts, oral papillomatosis treatment experienced |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Papilloma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Interferon-alpha Interferon Alfa-2a Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on February 26, 2013