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

NCT07545746 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: LCCC25313R37CA306827-01S2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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

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

Keywords

5-fluorouracil (5FU); thermal ablation (TA); placebo; intravaginal topical

Outcome Measures

Primary Outcomes (1)

• High-risk human papillomavirus (hrHPV) Clearance among WWH randomized to adjuvant self-administered 5FU cream versus placebo cream following Thermal ablation (TA)

  Vaginal samples will be collected at baseline and approximately every four weeks. Clearance of hrHPV genotypes will be assessed using Polymerase Chain Reaction (PCR)-based human papillomavirus (HPV) Deoxyribonucleic Acid (DNA) testing on these follow-up samples.

  Up to 24 weeks

Secondary Outcomes (3)

• Adverse Event per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  24 weeks

• Adverse Event per National Institute of Health (NIH) Division of Acquired Immunodeficiency Syndrome (AIDS) Adverse Event Grading Criteria (DAIDS)

  Up to 24 weeks

• Number of successful self-administration of the intravaginal cream by participants

  Up to 24 weeks

Study Arms (2)

5% 5-fluorouracil

EXPERIMENTAL

Participants will receive 12 doses of intravaginal 5FU cream.

Drug: 5% 5-fluorouracil Topical Cream

Placebo cream

PLACEBO COMPARATOR

Participants will receive 12 doses of intravaginal placebo cream.

Drug: Placebo Cream

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.

5% 5-fluorouracil

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.

Placebo cream

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Women aged 25 or older in Western Kenya who have both HIV and human papillomavirus (HPV) infections.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 25 years or older
• Known HIV-positive status
• On antiretroviral therapy (ART) for at least 60 days prior to enrollment
• Positive HPV screening test screening result
• Able to provide informed consent in English, Swahili, or Dholuo
• Agree to use dual contraception during dosing phase if of childbearing potential

You may not qualify if:

• Current pregnancy or breastfeeding
• History of anogenital cancer (cervical, vulvar, or anal)
• Current use of immunosuppressive medications
• History of total hysterectomy
• Known allergy to 5FU
• Medical comorbidity that would interfere with study participation
• Unwilling or unable to use contraception during study participation

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• UNC Department of Obstetrics and Gynecology: collaborator

Study Sites (2)

Maseno University

Kisumu, 614-40100, Kenya

Location

Nyanza Reproductive Health Society

Kisumu, Kenya

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

HIV Infections; Papillomavirus Infections; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Precancerous Conditions

Study Officials

• Chemtai Mungo, MD, MPH

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sorgi Kate

CONTACT

919-984-0000; kasorgi@email.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)