Treatment of Oral Warts in HIV+ Patients

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454181
• Other study ID #: 03HUHI19
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2007
• Last updated: September 12, 2011
• Start date: February 2007
• Est. completion date: October 2009

Study information

• Verified date: September 2011
• Source: Amarillo Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Papillomatosis

Intervention

Drug:
• Interferon-alpha
500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks

Other:
• placebo
200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks

Locations

Country	Name	City	State
United States	Medical College of Georgia School of Dentistry	Augusta	Georgia
United States	University of Maryland Baltimore Dental School	Baltimore	Maryland
United States	Division of Oral Medicine and Dentistry, Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Illinois at Chicago, College of Dentistry	Chicago	Illinois
United States	Baylor College of Dentistry	Dallas	Texas
United States	Nova Southeastern University College of Dental Medicine	Fort Lauderdale	Florida
United States	University of Kentucky College of Dentistry	Lexington	Kentucky
United States	New York University College of Dentistry	New York	New York
United States	UMDNJ - New Jersey Dental School	Newark	New Jersey
United States	University of Pennsylvania School of Dental Medicine	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of California, School of Dentistry	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Amarillo Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total Surface Area of the Lips Covered by Warts	Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area	24 weeks, from baseline to the end of treatment	No
Secondary	Subject Questionnaire Regarding Changes in Warts	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."	24 weeks, from baseline to the end of treatment	No
Secondary	Subject Questionnaire Regarding Global Oral Changes	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."	24 weeks, from baseline to end of treatment	No
Secondary	Investigator Assessment Regarding Changes in Warts	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."	24 weeks, from baseline to the end of treatment	No
Secondary	Investigator Assessment Regarding Global Oral Changes.	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."	24 weeks, from baseline to the end of treatment	No