Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Purpose
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).
Conditions
- CIN 2/3
- HPV Infection
- Pre-Cancerous Dysplasia
- Cervical Dysplasia
- HPV Related Disease
Eligibility
- Eligible Ages
- Between 25 Years and 100 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Participants, study team, and sponsor are blinded to the treatment assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Artesunate vaginal insert |
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4. |
|
|
Placebo Comparator Placebo vaginal inserts |
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. |
|
Recruiting Locations
Fort Myers, Florida 33905
Ann Arbor, Michigan 48109
Cleveland, Ohio 44111
Cleveland, Ohio 44195
Houston, Texas 77026
Houston, Texas 77030
More Details
- NCT ID
- NCT04098744
- Status
- Recruiting
- Sponsor
- Frantz Viral Therapeutics, LLC
Detailed Description
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