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A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children

Phase 1
2 Years
17 Years
Not Enrolling

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Trial Information

A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children

Your child will be assigned randomly (like tossing a coin) to receive either cidofovir or
placebo (an inactive substance). Neither you nor your doctor will know which your child is
receiving. Your child will undergo a total of 6 bronchoscopic procedures, which involves
placing a tube down your child's throat so that the warts can be seen and treated. The
warts will be removed by laser or other procedures and the study drug injected. Study drug
will be injected at the sites of all newly removed warts and warts which were removed during
earlier study visits. This procedure will be performed every other week. Blood and urine
tests will also be performed at this time. Your child will be under general anesthesia
during each procedure and will be in the surgery unit for about 6 to 8 hours. Your child
will also have to be seen by the doctor 2 days after the procedure. Your child will be
followed for a total of 5 years to make sure he/she develops normally and to monitor any
side effects of cidofovir. Follow-up visits will take place at Months 3, 6, and then once
every 6 months through Year 5. If necessary, laser or other procedures will be performed at
these visits to remove any warts.

Inclusion Criteria:

Your child may be eligible for this study if he/she:

- Has active laryngeal papillomatosis (warts in the throat) that requires 8 or more
surgeries per year.

- Developed this infection before the age of 16.

- Is between the ages of 2 and 17 years with consent of parent or guardian.

Exclusion Criteria:

Your child will not be eligible for this study if he/she:

- Has a history of a prior malignancy (cancer), kidney disease, or immune system

- Is HIV-positive.

- Is allergic to probenecid.

- Has received radiation therapy to the throat area or has received certain

- Is pregnant or breast-feeding.

Type of Study:


Study Design:

Masking: Double-Blind, Primary Purpose: Treatment


United States: Federal Government

Study ID:

DMID 97-023



Start Date:

Completion Date:

November 2005

Related Keywords:

  • Papilloma
  • Papilloma
  • Laryngeal Neoplasms



NIAID/DMID/CASG Central Unit Birmingham, Alabama  35294