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Not yet recruiting NCT07545746

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

Phase II Interventional HIV Infections HPV Infection Cervix Cancer CIN2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5% 5-fluorouracil Topical Cream, Placebo Cream.
Who it may be relevant to
Registry conditions: HIV Infections, HPV Infection, Cervix Cancer, CIN2. Basic parameters: from 25 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Kenya
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

WWH face up to six times higher risk of cervical cancer, a leading cause of death in this population. Cervical cancer is caused by persistent HPV infection, which can lead to cervical intraepithelial neoplasia grade 2/3 (CIN2/3), also called cervical precancer. If untreated, CIN2/3 can progress to cervical cancer. Thermal ablation (TA) is the most commonly used treatment for HPV/precancer in low- and middle-income countries, including Kenya. However, among WWH, TA has suboptimal efficacy, with only 44-66% clearing HPV or CIN2/3 at 6-12 months, compared to 83-95% in women without HIV. This highlights the need for adjuvant therapies to improve outcomes.

Studies in high-income countries suggest that off-label, self-administered intravaginal 5FU cream can improve HPV and CIN2/3 treatment outcomes in both HIV-negative and HIV-positive women. This trial will evaluate its potential as an adjuvant therapy following TA in WWH.

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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Adverse Event per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 [Time frame: 24 weeks]
  • Adverse Event per National Institute of Health (NIH) Division of Acquired Immunodeficiency Syndrome (AIDS) Adverse Event Grading Criteria (DAIDS) [Time frame: Up to 24 weeks]
  • Number of successful self-administration of the intravaginal cream by participants [Time frame: Up to 24 weeks]

Eligibility 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Kenya · 2 centers
  • Maseno University — Kisumu
  • Nyanza Reproductive Health Society — Kisumu

Identifiers

NCT: NCT07545746 · LCCC2531 · 3R37CA306827-01S2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗