Treatment of Oral Warts in HIV+ Patients

Primary Outcome Measures:

• Change in Total Oral Mucosal Area Covered by Warts. [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]
  Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area
  
  

Secondary Outcome Measures:

• Total Surface Area of the Lips Covered by Warts [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]
  Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area
  
  
• Subject Questionnaire Regarding Changes in Warts [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]
  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."
  
  
• Subject Questionnaire Regarding Global Oral Changes [ Time Frame: 24 weeks, from baseline to end of treatment ] [ Designated as safety issue: No ]
  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."
  
  
• Investigator Assessment Regarding Changes in Warts [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]
  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."
  
  
• Investigator Assessment Regarding Global Oral Changes. [ Time Frame: 24 weeks, from baseline to the end of treatment ] [ Designated as safety issue: No ]
  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."
  
  

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.