Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).

The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.

Phase I open-label dose escalation study of intravaginal artesunate, formulated in suppositories, in adult females with biopsy-confirmed CIN2/3. Thirty (30) subjects will undergo up to a total of three cycles of intravaginal artesunate. The first cycle will be initiated on Day 0, the second at Week 4, and the third and final cycle at week 8.

Inclusion Criteria:

• ≥ 18 years
• Capable of informed consent
• HPV-positive by DNA test
• Histologically confirmed CIN 2, CIN 3, or CIN 2/3
• Body weight ≥ 50 kg
• Immune competent

Exclusion Criteria:

• Pregnant and nursing women
• HIV seropositive
• Active autoimmune disease
• Taking immunosuppressive medication
• Evidence of concurrent adenocarcinoma in situ
• Concurrent malignancy except for nonmelanoma skin lesions