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

• Status: Not yet recruiting
• Trial end date: 2026-08-20
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fluorouracil

Criteria

Inclusion Criteria:

• Confirmed HIV-1 infection

• On antiretroviral therapy (ART), for at least 90 days prior to enrollment

• Cervical biopsy demonstrating CIN2/3 within the preceding 120 days.

Exclusion Criteria:

• pregnancy,

• breastfeeding,

• intend to become pregnant within 180 days of enrollment

• have an active sexually transmitted infection (women may participate once treated)

• have a surgically absent cervix

• have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer

• have a medical comorbidity that would interfere with study participation.