LCCC 2531: A Phase II Study of Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women with HIV in Kenya

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202601771235525

Enrollment

140

Registered

2026-01-30

Start date

2026-05-18

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

5fluorouracil

Dr. Wolffs vaginal moisturizer

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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 Planning to remain in study locale for duration of study (48 weeks)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare hrHPV clearance at 24 weeks among women living with HIV (WWH) randomized to adjuvant self-administered 5FU vs. Placebo cream following thermal ablation in Kenya.	—

Secondary

Measure	Time frame
To evaluate the safety of adjuvant 5FU vs placebo cream following thermal ablation among WWH in Kenya	—

Countries

Kenya

Contacts

Public ContactKatherine Sorgi

Research Coordinator Specialist

kasorgi@email.unc.edu+19196985283

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026