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

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.

Conditions

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

Interventions

DRUG

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.

DRUG

Placebo Cream

Starting four weeks after thermal ablation, participants will self-administer 2g of placebo cream intravaginally once every two weeks for 12 doses.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• UNC Department of Obstetrics and Gynecology

  collaborator UNKNOWN

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Chemtai Mungo, MD, MPH · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2027-09-30

Completion

2028-03-31

FDA Drug

Yes

Countries

• Kenya

Study Locations