Papilloma Clinical Trial
Official title:
A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children
The purpose of this study is to see what dose of the drug cidofovir is safe to treat
laryngeal papillomatosis (warts in the throat which occur over and over) in children.
Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus
(HPV). At present, there is no approved drug to treat this infection. However, cidofovir is
a drug effective against several viruses. Cidofovir may be able to attack the HPV virus.
This study tests the safety of giving this drug to children.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 17 Years |
Eligibility |
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 deficiency. - Is HIV-positive. - Is allergic to probenecid. - Has received radiation therapy to the throat area or has received certain medications. - Is pregnant or breast-feeding. |
Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | NIAID/DMID/CASG Central Unit | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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