Treatment of Oral Warts in HIV+ Patients

NCT ID: NCT00454181

Last Updated: 2011-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-10-31

Brief 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.

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.

Conditions

Papillomatosis; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IFN lozenges

500 IU Interferon-alpha lozenges for oral dissolution

Group Type: EXPERIMENTAL

Interferon-alpha

Intervention Type: DRUG

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

placebo lozenges

200 mg lozenges containing anhydrous crystalline maltose

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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

Interventions

Interferon-alpha

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

Intervention Type: DRUG

placebo

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

Intervention Type: OTHER

Other Intervention Names

Veldona; IFN-alpha lozenge; low dose IFN lozenge; maltose; sugar pill

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Greenspan, BDS, DSc

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, School of Dentistry

San Francisco, California, United States

Nova Southeastern University College of Dental Medicine

Fort Lauderdale, Florida, United States

Medical College of Georgia School of Dentistry

Augusta, Georgia, United States

University of Illinois at Chicago, College of Dentistry

Chicago, Illinois, United States

University of Kentucky College of Dentistry

Lexington, Kentucky, 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

UMDNJ - New Jersey Dental School

Newark, New Jersey, United States

New York University College of Dentistry

New York, New York, United States

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, United States

Baylor College of Dentistry

Dallas, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

03HUHI19

Identifier Type: -

Identifier Source: org_study_id