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

Completed · Phase 1

Conditions studied: Cervical Intraepithelial Neoplasia Grade 2/3, High-risk HPV (Any Strain)

In brief

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.

Key facts

Study ID

NCT02354534

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

30

Starts

2015-02-01

Expected to finish

2018-11-06

Last updated by the study team

2021-04-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Outpatient Center — Baltimore, Maryland, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Greater Baltimore Medical Center — Towson, Maryland, United States

Full record on ClinicalTrials.gov

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