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.
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
Current pregnancy or breastfeeding
History of anogenital cancer (cervical, vulvar, or anal)
Current use of immunosuppressive medications
History of total hysterectomy
Parallel
5% 5-fluorouracil Topical Cream
DrugStarting four weeks after thermal ablation, participants will self-administer 2 g of 5FU cream intravaginally once every two weeks for 12 doses.
Placebo Cream
DrugStarting four weeks after thermal ablation, participants will self-administer 2g of placebo cream intravaginally once every two weeks for 12 doses.
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.
Adverse Event per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Type, frequency, severity and duration of adverse events (AEs) using NCI CTCAE v5.0 will be reported. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Adverse Event per National Institute of Health (NIH) Division of Acquired Immunodeficiency Syndrome (AIDS) Adverse Event Grading Criteria (DAIDS)
Type, frequency, severity and duration of adverse events (AEs) using per DAIDS standardized scales will be reported. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, Grade 5 indicates death.
Number of successful self-administration of the intravaginal cream by participants
Number of confirmed successful self-administrations of intravaginal 5FU or placebo cream by participants.
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
UNC Department of Obstetrics and Gynecology
Collaborator
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