Treatment of Oral Warts in HIV+ Patients
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ClinicalTrials.gov Identifier: NCT00454181 |
Recruitment Status
:
Completed
First Posted
: March 30, 2007
Results First Posted
: January 13, 2011
Last Update Posted
: September 16, 2011
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Papillomatosis HIV Infections | Drug: Interferon-alpha Other: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | October 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: IFN lozenges
500 IU Interferon-alpha lozenges for oral dissolution
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Drug: Interferon-alpha
500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks
Other Names:
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Placebo Comparator: placebo lozenges
200 mg lozenges containing anhydrous crystalline maltose
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Other: placebo
200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks
Other Names:
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- Change in Total Oral Mucosal Area Covered by Warts. [ Time Frame: 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
- Total Surface Area of the Lips Covered by Warts [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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."

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454181
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 |
Responsible Party: | Amarillo Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00454181 History of Changes |
Other Study ID Numbers: |
03HUHI19 |
First Posted: | March 30, 2007 Key Record Dates |
Results First Posted: | January 13, 2011 |
Last Update Posted: | September 16, 2011 |
Last Verified: | September 2011 |
Keywords provided by Amarillo Biosciences, Inc.:
human immunodeficiency virus human papilloma virus warts, oral papillomatosis treatment experienced |
Additional relevant MeSH terms:
HIV Infections Papilloma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Squamous Cell |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Interferons Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |