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
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Amarillo Biosciences, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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:
  • Veldona
  • IFN-alpha lozenge
  • low dose IFN lozenge
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:
  • maltose
  • sugar pill

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454181

Locations
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
Sponsors and Collaborators
Amarillo Biosciences, Inc.
Investigators
Principal Investigator: Deborah Greenspan, BDS, DSc University of California, San Francisco
  More Information

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
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014