Status:
ACTIVE_NOT_RECRUITING
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
CIN2
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
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 neopla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05413811
Start Date
March 22 2023
End Date
August 24 2025
Last Update
May 7 2025
Active Locations (1)
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1
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, South Africa, 2092