Treatment of Oral Warts in HIV+ Patients
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.
Human papilloma virus (HPV)
can cause oral 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 oral 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 oral 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.
Subjects will be reimbursed
for travel expenses related to making the 6 clinic visits required during
the study.
To qualify, you must:
You will not qualify if you:
- Are taking oral or injected steroids
- Are taking other drugs for treatment of oral warts
- Have any active AIDS-related opportunistic infections, such as Kaposi’s sarcoma, pneumocystis carinii pneumonia or tuberculosis
