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Treatment of Oral Warts in HIV+ Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00454181
First received: March 29, 2007
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
Results First Received: November 9, 2010  
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
Conditions: Papillomatosis
HIV Infections
Interventions: Drug: Interferon-alpha
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment took place between January 2007 and March 2009 at 10 university-affiliated dental clinics across the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 59 enrolled subjects were randomized to treatment and took at least 1 dose of assigned study drug.

Reporting Groups
  Description
IFN Lozenges 500 IU Interferon-alpha lozenges for oral dissolution
Placebo Lozenges 200 mg lozenges containing anhydrous crystalline maltose

Participant Flow:   Overall Study
    IFN Lozenges     Placebo Lozenges  
STARTED     45     14  
COMPLETED     30     11  
NOT COMPLETED     15     3  
Adverse Event                 1                 1  
Lost to Follow-up                 11                 1  
Protocol Violation                 1                 1  
Withdrawal by Subject                 2                 0  



  Baseline Characteristics
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Reporting Groups
  Description
IFN Lozenges 500 IU Interferon-alpha lozenges for oral dissolution
Placebo Lozenges 200 mg lozenges containing anhydrous crystalline maltose
Total Total of all reporting groups

Baseline Measures
    IFN Lozenges     Placebo Lozenges     Total  
Number of Participants  
[units: participants]
 		  45     14     59  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     45     14     59  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  45.0  ± 5.05     46.6  ± 5.43     45.4  ± 5.14  
Gender  
[units: participants]
 		     
Female     5     1     6  
Male     40     13     53  
Region of Enrollment  
[units: participants]
 		     
United States     45     14     59  



  Outcome Measures
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1.  Primary:   Change in Total Oral Mucosal Area Covered by Warts.   [ Time Frame: 24 weeks, from baseline to the end of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Total Surface Area of the Lips Covered by Warts   [ Time Frame: 24 weeks, from baseline to the end of treatment ]
  Show Outcome Measure 2

3.  Secondary:   Subject Questionnaire Regarding Changes in Warts   [ Time Frame: 24 weeks, from baseline to the end of treatment ]
  Show Outcome Measure 3

4.  Secondary:   Subject Questionnaire Regarding Global Oral Changes   [ Time Frame: 24 weeks, from baseline to end of treatment ]
  Show Outcome Measure 4

5.  Secondary:   Investigator Assessment Regarding Changes in Warts   [ Time Frame: 24 weeks, from baseline to the end of treatment ]
  Show Outcome Measure 5

6.  Secondary:   Investigator Assessment Regarding Global Oral Changes.   [ Time Frame: 24 weeks, from baseline to the end of treatment ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only 59 of 80 planned subjects were randomized, so statistical power of the study was limited.  


Results Point of Contact:  
Name/Title: Martin J. Cummins
Organization: Amarillo Biosciences, Inc.
phone: 806-376-1741 ext 14
e-mail: mcummins@amarbio.com


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