A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women
Women with HIV infection are at greater risk for cervical dysplasia. Because of the
likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer,
there is an urgent need to develop appropriate therapies.
Patients are randomized to receive either intravaginal fluorouracil or no treatment
(observation only). Fluorouracil cream is self-administered via applicator at biweekly
intervals for 6 months. Patients are evaluated for recurrent cervical dysplasia by cytology
and colposcopy with or without biopsy.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention
Maiman M
Study Chair
United States: Federal Government
ACTG 200
NCT00000758
April 1998
Name | Location |
---|---|
Univ. of Miami AIDS CRS | Miami, Florida 33136 |
Northwestern University CRS | Chicago, Illinois 60611 |
Cook County Hosp. CORE Ctr. | Chicago, Illinois 60612 |
Tulane/LSU Maternal/Child CRS | New Orleans, Louisiana 70112 |
Johns Hopkins Adult AIDS CRS | Baltimore, Maryland 21287 |
Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston, Massachusetts 02215 |
Bmc Actg Crs | Boston, Massachusetts 02118 |
NJ Med. School CRS | Newark, New Jersey |
SUNY - Buffalo, Erie County Medical Ctr. | Buffalo, New York 14215 |
Memorial Sloan-Kettering Cancer Ctr. | New York, New York 10021 |
Univ. of Rochester ACTG CRS | Rochester, New York 14642 |
Unc Aids Crs | Chapel Hill, North Carolina 27599 |
Univ. of Cincinnati CRS | Cincinnati, Ohio 45267 |
Usc La Nichd Crs | Los Angeles, California 90033 |
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago, Illinois 60637 |
Children's Hospital of Michigan NICHD CRS | Detroit, Michigan 48201 |
Bronx-Lebanon Hosp. IMPAACT CRS | Bronx, New York 10457 |
SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse, New York 13210 |
UW School of Medicine - CHRMC | Seattle, Washington 98122 |