Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)

A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17.

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 vaginal 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 viral clearance after three 5-day cycles of artesunate and the LEEP procedure

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 cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
• Women of childbearing potential agree to use birth control through week17 of the study.
• 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