Brief Title
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Official Title
A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
Brief Summary
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).
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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Proportion of participants with histologic regression by week 17
Secondary Outcome
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17
Condition
CIN 2/3
Intervention
Artesunate vaginal insert
Study Arms / Comparison Groups
Artesunate vaginal insert
Description: Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
78
Start Date
September 9, 2020
Completion Date
December 31, 2024
Primary Completion Date
December 31, 2023
Eligibility Criteria
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 week 28 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
Gender
Female
Ages
25 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
, 440-255-1155, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04098744
Organization ID
ART-CIN IIB
Secondary IDs
2020 0237
Responsible Party
Sponsor
Study Sponsor
Frantz Viral Therapeutics, LLC
Collaborators
Amarex Clinical Research
Study Sponsor
, ,
Verification Date
January 2023