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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Papillomatosis, HIV Infections

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Trial Information

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


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.


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.

Type of Study:

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

Outcome Measure:

Change in Total Oral Mucosal Area Covered by Warts.

Outcome Description:

Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area

Outcome Time Frame:

24 weeks, from baseline to the end of treatment

Safety Issue:

No

Principal Investigator

Deborah Greenspan, BDS, DSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

03HUHI19

NCT ID:

NCT00454181

Start Date:

February 2007

Completion Date:

October 2009

Related Keywords:

  • Papillomatosis
  • HIV Infections
  • human immunodeficiency virus
  • human papilloma virus
  • warts, oral
  • papillomatosis
  • treatment experienced
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Papilloma

Name

Location

University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Baylor College of DentistryDallas, Texas  75246
University of California, School of DentistrySan Francisco, California  94143
Nova Southeastern University College of Dental MedicineFort Lauderdale, Florida  33328-2018
Medical College of Georgia School of DentistryAugusta, Georgia  30912-1241
University of Illinois at Chicago, College of DentistryChicago, Illinois  60612
University of Kentucky College of DentistryLexington, Kentucky  40536-0297
University of Maryland Baltimore Dental SchoolBaltimore, Maryland  21201
Division of Oral Medicine and Dentistry, Brigham and Women's HospitalBoston, Massachusetts  02115
UMDNJ - New Jersey Dental SchoolNewark, New Jersey  07108
New York University College of DentistryNew York, New York  10010
University of Pennsylvania School of Dental MedicinePhiladelphia, Pennsylvania  19104