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.