Adjuvant 5-Fluorouracil Following Thermal Ablation for HPV in Kenyan Women With HIV
Summary
This Phase 2 randomized, placebo-controlled clinical trial (NCT07545746) will evaluate self-administered 5% 5-fluorouracil (5FU) cream versus placebo to improve human papillomavirus (HPV) clearance after thermal ablation in women with HIV in Kenya. Participants will self-administer the cream intravaginally once every other week for 12 applications starting four weeks post-ablation, with clinic follow-up through 48 weeks. The trial's hypothesis is that 5FU will increase HPV clearance at 24 weeks and prove safe, well-tolerated, and acceptable in this population.
“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.”
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What changed
This ClinicalTrials.gov registry entry documents a new Phase 2 clinical trial (NCT07545746) sponsored by the NIH, evaluating 5% 5-fluorouracil topical cream versus placebo in women with HIV undergoing thermal ablation for HPV-related cervical lesions in Kenya. The trial plans 12 biweekly intravaginal applications beginning four weeks post-ablation, with evaluation visits at weeks 2, 8, 16, 24, and 48. No compliance obligations or required actions are imposed on external parties; the document is informational, describing trial design, interventions, and hypotheses.
Affected parties — including clinical investigators, pharmaceutical companies with topical 5-FU products, and public-health authorities focused on cervical cancer prevention in sub-Saharan Africa — should note this trial as a source of forthcoming evidence on self-administered intravaginal 5-FU in an immunocompromised population with high cervical cancer burden.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
Phase 2 NCT07545746 Kind: PHASE2 Apr 22, 2026
Abstract
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.
Conditions: HIV Infections, HPV Infection, Cervix Cancer, CIN2, CIN3, CIN1, CIN
Interventions: 5% 5-fluorouracil Topical Cream, Placebo Cream
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