NCT05413811

Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Cancer
• CIN2
• CIN3
• Human Immunodeficiency Virus
• Human Papillomavirus

Interventions

Type	Name	Description
DRUG	5 Fluorouracil (5 FU) Cream	Intravaginal topical chemotherapy, 5-fluorouracil cream
DRUG	Placebo	Intravaginal topical placebo cream

Timeline

• Start date: 2023-03-22
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-06-10
• Last updated: 2026-02-17

Locations

1 site across 1 country: South Africa