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
1 other identifier
interventional
59
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2007
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 29, 2007
CompletedFirst Posted
Study publicly available on registry
March 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
January 13, 2011
CompletedSeptember 16, 2011
September 1, 2011
2.6 years
March 29, 2007
November 9, 2010
September 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Total Surface Area of the Lips Covered by Warts
24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Changes in Warts
24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Global Oral Changes
24 weeks, from baseline to end of treatment
Investigator Assessment Regarding Changes in Warts
24 weeks, from baseline to the end of treatment
Investigator Assessment Regarding Global Oral Changes.
24 weeks, from baseline to the end of treatment
Study Arms (2)
IFN lozenges
EXPERIMENTAL500 IU Interferon-alpha lozenges for oral dissolution
placebo lozenges
PLACEBO COMPARATOR200 mg lozenges containing anhydrous crystalline maltose
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of California, School of Dentistry
San Francisco, California, 94143, United States
Nova Southeastern University College of Dental Medicine
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only 59 of 80 planned subjects were randomized, so statistical power of the study was limited.
Results Point of Contact
- Title
- Martin J. Cummins
- Organization
- Amarillo Biosciences, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Greenspan, BDS, DSc
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2007
First Posted
March 30, 2007
Study Start
February 1, 2007
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
September 16, 2011
Results First Posted
January 13, 2011
Record last verified: 2011-09