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The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.
There are currently no medical therapies recommended to promote the clearance of humanpapilloma virus (HPV) infection, regression of cervical dysplasia, or treatment of cervical intraepithelial neoplasia (CIN). Human immunodeficiency virus (HIV) -infected women are at higher risk of HPV infection, with rates as high as 45% - 90%. Despite being preventable, cytologic abnormalities, cervical precancer (high-grade cervical intraepithelial neoplasia \[CIN2/3\]), and invasive cervical cancer also occur more frequently in HIV infected women. This study is testing whether topical 5-fluorouracil (5FU) can be used as a patient-controlled adjuvant treatment for cervical precancer (CIN2/3) to be self-administered after surgical excision to reduce the risk of persistent/recurrent CIN2/3 and progression to cervical cancer among HIV-infected women.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, South Africa
Start Date
March 22, 2023
Primary Completion Date
June 30, 2025
Completion Date
June 30, 2025
Last Updated
February 17, 2026
180
ACTUAL participants
5 Fluorouracil (5 FU) Cream
DRUG
Placebo
DRUG
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
NCT06349642
NCT05639972
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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