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Completed

NCT Number: NCT00454181

Treatment of Oral Warts in HIV+ Patients

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.

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Key information

Conditions

Papillomatosis Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases DNA Virus Infections Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Papilloma Papillomavirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Slow Virus Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, School of Dentistry, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferon-alpha

Drug

500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks

Other names: Veldona, IFN-alpha lozenge, low dose IFN lozenge

Placebo

Other

200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks

Other names: maltose, sugar pill

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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."

  3. 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."

  4. 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."

  5. 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."

Sponsors and collaborators

Lead sponsor

Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 30, 2007
Registry last updated
Sep 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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