This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).
Adult women age ≥ 18 years
Capable of informed consent
Able to collaborate with planned follow-up (transportation, compliance history, etc)
Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry.
Pregnant and nursing women
Concurrent anal, vulvar, or cervical cancer
HIV-positive participants with a CD4 count < 200
Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.
Parallel
Artesunate ointment
Drugtopical ointment, as a non-surgical treatment
Placebo ointment
Drugtopical placebo ointment
Number of participants with complete histologic response
Number of participants who have complete histologic response following topical artesunate ointment
Number of participants who have achieved viral clearance
Number of participants who achieve clearance of HPV genotypes present at screening. These genotypes become undetectable over the study window.
Number of participants who show partial response
Number of participants with documented partial response following topical artesunate
Number of participants who have durable response
Number of participants with documented complete response who do not have recurrence of their vulvar HSIL over the study window
Incidence of Treatment-Emergent Adverse Events (TEAE)
Number of participants who report artesunate-related serious adverse events
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Frantz Viral Therapeutics, LLC
Lead sponsor
The Cleveland Clinic
Collaborator
