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
- Conditions
- HIV InfectionsCervix, Dysplasia
- Registration Number
- NCT00000758
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 158
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Usc La Nichd Crs
🇺🇸Los Angeles, California, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
NJ Med. School CRS
🇺🇸Newark, New Jersey, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
🇺🇸Chicago, Illinois, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
UW School of Medicine - CHRMC
🇺🇸Seattle, Washington, United States
Children's Hospital of Michigan NICHD CRS
🇺🇸Detroit, Michigan, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Memorial Sloan-Kettering Cancer Ctr.
🇺🇸New York, New York, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico