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Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
This randomized, placebo-controlled trial will evaluate self-administered 5-fluorouracil (5FU) to improve human papillomavirus (HPV) clearance after thermal ablation (TA) in Women With Human Immunodeficiency Virus (HIV) (WWH) in Kenya. The trial will also assess the safety, adherence, and acceptability of 5FU. Starting four weeks after TA, participants will self-administer 5FU cream or matched placebo intravaginally once every other week for 12 applications, with clinic visits at weeks 2, 8, 16, 24, and 48 for evaluation. All participants will be followed up to 48 weeks. It is hypothesized that, compared to placebo, 5FU will increase HPV clearance at 24 weeks and that the proposed dosing schedule will be safe, well-tolerated, and acceptable in this population. Together with data from other studies, this trial will provide evidence on the use of self-administered intravaginal 5FU to improve HPV treatment outcomes in WWH in low- and middle-income countries, where the burden of cervical cancer is highest.
Key Details
Gender
FEMALE
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-05
Completion Date
2028-03
Last Updated
2026-04-22
Healthy Volunteers
No
Interventions
5% 5-fluorouracil Topical Cream
Starting four weeks after thermal ablation, participants will self-administer 2 g of 5FU cream intravaginally once every two weeks for 12 doses.
Placebo Cream
Starting four weeks after thermal ablation, participants will self-administer 2g of placebo cream intravaginally once every two weeks for 12 doses.
Locations (2)
Maseno University
Kisumu, Kenya
Nyanza Reproductive Health Society
Kisumu, Kenya