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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05413811
Study type Interventional
Source UNC Lineberger Comprehensive Cancer Center
Contact Cheryl Hendrickson
Phone +1 (919) 843-2541
Email cheryl_hendrickson@med.unc.edu
Status Recruiting
Phase N/A
Start date March 22, 2023
Completion date December 31, 2025

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