Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07545746
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • CIN
  • CIN1
  • CIN2
  • CIN3
  • Cervical Intraepithelial Neoplasia Grade 1
  • Cervical Intraepithelial Neoplasia Grade 2/3
  • Cervical Intraepithelial Neoplasia Grade 3
  • Cervix Cancer
  • HIV Infections
  • HPV Infection

Eligibility Criteria

Sex
FEMALE
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5% 5-fluorouracil Topical Cream — DRUG
    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 — DRUG
    Starting four weeks after thermal ablation, participants will self-administer 2g of placebo cream intravaginally once every two weeks for 12 doses.

Study Details

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 Dates

First listed
Apr 22, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5% 5-fluorouracil
    Participants will receive 12 doses of intravaginal 5FU cream.
  • Placebo Comparator: Placebo cream
    Participants will receive 12 doses of intravaginal placebo cream.

Primary Outcome Measure

High-risk human papillomavirus (hrHPV) Clearance among WWH randomized to adjuvant self-administered 5FU cream versus placebo cream following Thermal ablation (TA) [ Time Frame: Up to 24 weeks ]

Central Contacts

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