NCT00001126

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2000

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 27, 2010

Status Verified

November 1, 2005

First QC Date

January 17, 2000

Last Update Submit

August 26, 2010

Conditions

Papilloma

Interventions

CidofovirDRUG

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIAID/DMID/CASG Central Unit

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Papilloma

Interventions

Cidofovir

Condition Hierarchy (Ancestors)

Neoplasms, Squamous CellNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCytosinePyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 17, 2000

First Posted

August 31, 2001

Study Completion

November 1, 2005

Last Updated

August 27, 2010

Record last verified: 2005-11

Locations

US(1)