Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001126
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2000-01-17
Brief Title:
Treatment With Cidofovir for Children With Laryngeal Papillomatosis Warts in the Throat
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 childs 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 heshe 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: