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

March 29, 2007
September 12, 2011
February 2007
September 2009   (final data collection date for primary outcome measure)
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
Change in total oral mucosal area covered by warts.
Complete list of historical versions of study NCT00454181 on ClinicalTrials.gov Archive Site
  • 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."
  • Total surface area of the lips covered by warts
  • Subject questionnaire regarding changes in warts
  • Subject questionnaire regarding global oral changes
  • Investigator assessment regarding changes in warts
  • Investigator assessment regarding global oral changes.
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Papillomatosis
  • HIV Infections
  • Drug: Interferon-alpha
    500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks
    Other Names:
    • Veldona
    • IFN-alpha lozenge
    • low dose IFN lozenge
  • Other: placebo
    200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks
    Other Names:
    • maltose
    • sugar pill
  • Experimental: IFN lozenges
    500 IU Interferon-alpha lozenges for oral dissolution
    Intervention: Drug: Interferon-alpha
  • Placebo Comparator: placebo lozenges
    200 mg lozenges containing anhydrous crystalline maltose
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
October 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00454181
03HUHI19
No
Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc.
Not Provided
Principal Investigator: Deborah Greenspan, BDS, DSc University of California, San Francisco
Amarillo Biosciences, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP