Clinical trial NCT00454181: Treatment of Oral Warts in HIV+ Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Papillomatosis
HIV Infections
Keywords: human immunodeficiency virus
human papilloma virus
warts, oral
papillomatosis
treatment experienced
Lead sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Total Oral Mucosal Area Covered by Warts.
timeFrame: 24 weeks, from baseline to the end of treatment
Secondary outcomes:
measure: Total Surface Area of the Lips Covered by Warts
timeFrame: 24 weeks, from baseline to the end of treatment
measure: Subject Questionnaire Regarding Changes in Warts
timeFrame: 24 weeks, from baseline to the end of treatment
measure: Subject Questionnaire Regarding Global Oral Changes
timeFrame: 24 weeks, from baseline to end of treatment
measure: Investigator Assessment Regarding Changes in Warts
timeFrame: 24 weeks, from baseline to the end of treatment
measure: Investigator Assessment Regarding Global Oral Changes.
timeFrame: 24 weeks, from baseline to the end of treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, School of Dentistry
state: California
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University College of Dental Medicine
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia School of Dentistry
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago, College of Dentistry
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky College of Dentistry
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Baltimore Dental School
state: Maryland
city: Boston
country: United States
facility: Division of Oral Medicine and Dentistry, Brigham and Women's Hospital
state: Massachusetts
city: Newark
country: United States
facility: UMDNJ - New Jersey Dental School
state: New Jersey
city: New York
country: United States
facility: New York University College of Dentistry
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Dental Medicine
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor College of Dentistry
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Deborah Greenspan, BDS, DSc
role: PRINCIPAL_INVESTIGATOR
References: