IRB Study Number 20-1148
Status Recruiting
Phase Phase 2
Institutes Taussig Cancer Institute, Obstetrics and Gynecology and Women's Health Institute
Description
PRIMARY OBJECTIVE
To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
SECONDARY OBJECTIVES
• To evaluate the safety of artesunate intravaginal inserts for the treatment of CIN2/3
• To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
• To evaluate histopathologic regression after the week 15 time point
Inclusion Criteria
Adult females age ≥ 25 years
Capable of informed consent
Any HPV genotype-detectable by DNA test/HPV genotyping
Colposcopically-directed, histologically confirmed tissue diagnosis of either CIN2, CIN3, or CIN2/3
Women of childbearing potential agree to use birth control through the week 28 visit.
Weight ≥ 50kg
Exclusion Criteria
Pregnant and nursing women
Active autoimmune disease
Taking immunosuppressive medication
HIV seropositivity
Immunocompromised subjects
Evidence of concurrent cervical adenocarcinoma in situ
Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects
