Use of Cidofovir for RRP

This study is ongoing, but not recruiting participants.

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00205374

Purpose

Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx in the pediatric population. The impact of the disease on patients and families can be tremendous due to the need for frequent treatment. It would be highly beneficial to develop effective medical therapies as adjunctive measures to surgical ablation with the goal of reducing the frequency of reoccurrence. The use of cidofovir injectio

Condition	Intervention	Phase
RRP	Drug: Cidofovir vs. placebo	Phase IV

Drug Information available for: Cidofovir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Use of Cidofovir Injection in the Treatment of Recurrent Respiratory Papillomatosis.”

Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment:	20
Study Start Date:	November 1999

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

4 surgeries for RRP in last 12 months

Exclusion Criteria:

Renal insufficiency
Nephrotoxic drugs in the last 7 days
Sulfa allergies
Currently treated with systemic or topical HPV chemotherapeutic agents
Females of childbearing potential with a positive pregnancy test
Women who are breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205374

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

J Scott McMurray, MD

University of Wisconsin Medical School

More Information

Study ID Numbers:	1999-196
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00205374
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cidofovir
Recurrent respiratory papillomatosis
Recurrence

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
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 16, 2009