Description:
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).
Participants who receive placebo in this study have the option to receive active drug
(artesunate) after their week 15 colposcopy visit.
Title
- 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)
Clinical Trial IDs
- ORG STUDY ID:
ART-CIN IIB
- SECONDARY ID:
2020 0237
- SECONDARY ID:
20 1148
- NCT ID:
NCT04098744
Conditions
- CIN 2/3
- HPV Infection
- Pre-Cancerous Dysplasia
- Cervical Dysplasia
- HPV Related Disease
Interventions
Drug | Synonyms | Arms |
---|
Artesunate vaginal insert | Artesunic acid, DHA, artemisinin | Artesunate vaginal insert |
Placebo vaginal insert | | Placebo vaginal inserts |
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).
Participants who receive placebo in this study have the option to receive active drug
(artesunate) after their week 15 colposcopy visit.
Detailed Description
Eligible participants in this study are randomized 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 closely with
colposcopies at weeks 6, 15, and 28. After the week 15 colposcopy visit the investigator is
unblinded. Participants in the placebo group who still have CIN2/3 have the option to start
treatment with artesunate within 4 weeks. Participants in the artesunate treatment who still
have CIN2/3 at the week 15 visit, will undergo standard of care surgical treatment (LEEP or
cold knife conization) within 6 weeks.
Primary Objective: To evaluate the histopathologic regression after 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 histopathologic regression after the week 15 time point
Trial Arms
Name | Type | Description | Interventions |
---|
Artesunate vaginal insert | Experimental | Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4. | - Artesunate vaginal insert
|
Placebo vaginal inserts | Placebo Comparator | Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. Unblinding will take place at week 15. Participants who do not have histologic regression at week 15 will have the opportunity to cross over to the experimental arm, and start treatment with artesunate vaginal inserts within 4 weeks of the week 15 visit. | |
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 either 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
Maximum Eligible Age: | 100 Years |
Minimum Eligible Age: | 25 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Proportion of participants with histologic regression by week 15 |
Time Frame: | 15 weeks |
Safety Issue: | |
Description: | Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 15, following 3 cycles of artesunate vaginal inserts, as determined by biopsy histopathologic analysis |
Secondary Outcome Measures
Measure: | Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 15 |
Time Frame: | 15 weeks |
Safety Issue: | |
Description: | Number of participants who had HPV strains detected at study entry which become undetectable within the study window (15 weeks) |
Measure: | Proportion of participants with histologic regression after week 15 |
Time Frame: | 21 weeks |
Safety Issue: | |
Description: | Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less after week 15 following 3 cycles of artesunate vaginal inserts, as determined by biopsy histopathologic analysis |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Frantz Viral Therapeutics, LLC |
Trial Keywords
- treatment study
- cancer prevention
- non-surgical
- HPV related disease
- CIN
- topical treatment
- vaginal inserts
- artesunate
- artemisinin
- non-invasive
- high risk HPV
- vaginal suppository
Last Updated
June 30, 2021