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Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001126
  Purpose

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.


Condition Intervention Phase
Papilloma
Drug: Cidofovir
Phase I

MedlinePlus related topics: Warts
Drug Information available for: Cidofovir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind
Official Title: A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 36
Estimated Study Completion Date: November 2005
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 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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001126

Locations
United States, Alabama
NIAID/DMID/CASG Central Unit
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
  More Information

Study ID Numbers: DMID 97-023
Study First Received: January 17, 2000
Last Updated: November 11, 2005
ClinicalTrials.gov Identifier: NCT00001126  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Cidofovir
Warts
Laryngeal papillomatosis
Neoplasms, Squamous Cell
Papilloma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Anti-HIV Agents
Neoplasms by Histologic Type
Anti-Retroviral Agents
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009