Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
NCT ID: NCT06519994
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-01-22
2026-04-08
Brief Summary
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The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Artesunate vaginal inserts
Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).
Artesunate vaginal inserts
Subjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5.
Placebo vaginal inserts
Participants will self-administer the study placebo nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).
Placebo vaginal inserts
Subjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5.
Interventions
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Artesunate vaginal inserts
Subjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5.
Placebo vaginal inserts
Subjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5.
Eligibility Criteria
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Inclusion Criteria
* Known HIV seropositive status
* On antiretroviral therapy for \> 90 days prior to enrollment
* Weight ≥50 Kg at study entry\*
* Positive HPV screening test and within 4-8 weeks of thermal ablation
* Ability to provide informed consent
* Planning to stay within the study locale during the duration of the study (24 weeks)
* Agreement to use contraception (barriers or hormonal) if of childbearing age through week 6 of the study
Exclusion Criteria
* Current or past history of invasive cervical cancer
* History of total hysterectomy
* Currently receiving systemic chemotherapy or radiation therapy for another cancer
* Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent)
* Current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin
* Have medical comorbidity that, in the opinion of the investigator, would interfere with study participation
* Prior chemotherapy within 30 days prior to day 1 of study treatment
* Male at birth
25 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Kenya Medical Research Institute
OTHER
Maseno University School of Medicine, Kenya
UNKNOWN
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Chemtai Mungo, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Kisumu, , Kenya
Countries
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References
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Sadana A, Omoto J, Sorgi K, Rahangdale L, Smith JS, Plesa M, Mungo C. Feasibility of Intravaginal Artesunate as an Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya: Study Protocol for a Phase II Clinical Trial. Cancer Control. 2025 Jan-Dec;32:10732748251374418. doi: 10.1177/10732748251374418. Epub 2025 Sep 4.
Related Links
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Clinical trials at UNC Lineberger
Other Identifiers
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LCCC2330
Identifier Type: -
Identifier Source: org_study_id