HPV Infection Clinical Trial
— ART-VIN IIBOfficial title:
A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)
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).
Status | Recruiting |
Enrollment | 27 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. - Positive HPV test at study entry (any genotype). - Women of childbearing potential agree to use birth control during the dosing phase (through week 8). - Laboratory values at Screening of: - Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN) - Serum aspartate transaminase (SGOT/AST) < 5 x ULN - Serum Bilirubin (total) < 2.5 x ULN - Serum Creatinine = 1.5 x ULN - Weight = 50kg Exclusion Criteria: - 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. - Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry. - Currently receiving systemic chemotherapy or radiation therapy for another cancer. - Concomitant use of Efavirenz for HIV antiretroviral treatment - Concomitant use of strong UGT inhibitors - Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study - Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy). - Concurrent treatment with systemic corticosteroids |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Fairview Hospital | Cleveland | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Florida Gynecologic Oncology | Fort Myers | Florida |
United States | Hillcrest Hospital | Mayfield Heights | Ohio |
Lead Sponsor | Collaborator |
---|---|
Frantz Viral Therapeutics, LLC | The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with complete histologic response | Number of participants who have complete histologic response following topical artesunate ointment | 18 weeks | |
Secondary | 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. | Week 18 | |
Secondary | Number of participants who show partial response | Number of participants with documented partial response following topical artesunate | Week 18 | |
Secondary | 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 | Week 18 | |
Secondary | Incidence of Treatment-Emergent Adverse Events (TEAE) | Number of participants who report artesunate-related serious adverse events | 8 weeks |
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