Phase 1
N=30
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Cervical Intraepithelial Neoplasia Grade 2/3 · High-risk HPV (Any Strain)
Bottom Line
View on ClinicalTrials.gov: NCT02354534 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Serious Adverse Events — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Artesunate Suppositories (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events |
0; 0; 0; 0 | — |
| SECONDARY Viral Clearance of HPV |
1; 3; 4; 1 | — |
| SECONDARY Histologic Regression of CIN2/3 |
2; 7; 5; 5 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02354534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.