Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT00000758
Interventions
Study Description
Brief Summary: To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function. 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.
Detailed Description: 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.
Eligibility
Minimum Age: 13 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Usc La Nichd Crs, Los Angeles, California, United States
Univ. of Miami AIDS CRS, Miami, Florida, United States
Northwestern University CRS, Chicago, Illinois, United States
Cook County Hosp. CORE Ctr., Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States
Bmc Actg Crs, Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS, Detroit, Michigan, United States
NJ Med. School CRS, Newark, New Jersey, United States
Bronx-Lebanon Hosp. IMPAACT CRS, Bronx, New York, United States
SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Ctr., New York, New York, United States
Univ. of Rochester ACTG CRS, Rochester, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds., Syracuse, New York, United States
Unc Aids Crs, Chapel Hill, North Carolina, United States
Univ. of Cincinnati CRS, Cincinnati, Ohio, United States
UW School of Medicine - CHRMC, Seattle, Washington, United States
Puerto Rico-AIDS CRS, San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS, San Juan, , Puerto Rico
Contact Details
Name: Maiman M
Affiliation:
Role: STUDY_CHAIR
Name: Watts DH
Affiliation:
Role: STUDY_CHAIR
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