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

Status and phase

Completed
Phase 1

Conditions

High-risk HPV (Any Strain)
Cervical Intraepithelial Neoplasia Grade 2/3

Treatments

Drug: Artesunate Suppositories

Study type

Interventional

Funder types

Other

Identifiers

NCT02354534
IRB00045376 (Other Identifier)
J1498

Details and patient eligibility

About

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.

Full description

Phase I open-label dose escalation study of intravaginal artesunate, formulated in suppositories, in adult females with biopsy-confirmed CIN2/3. Thirty (30) subjects will undergo up to a total of three cycles of intravaginal artesunate. The first cycle will be initiated on Day 0, the second at Week 4, and the third and final cycle at week 8.

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 4 patient groups

50 mg Artesunate suppositories, 1 cycle
Experimental group
Description:
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Treatment:
Drug: Artesunate Suppositories
200 mg Artesunate suppositories, 1 cycle
Experimental group
Description:
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Treatment:
Drug: Artesunate Suppositories
200 mg Artesunate suppositories,2 cycles
Experimental group
Description:
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Treatment:
Drug: Artesunate Suppositories
200 mg Artesunate suppositories,3 cycles
Experimental group
Description:
Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Treatment:
Drug: Artesunate Suppositories

Trial contacts and locations

3

There are currently no registered sites for this trial.

Timeline

Last updated: Apr 28, 2021

Start date

Feb 01, 2015 • 10 years ago

End date

Jul 01, 2018 • 6 years ago

Results posted

View

Apr 02, 2021 • 4 years ago

Today

May 12, 2025

Sponsors of this trial

Collaborating Sponsor

Data sourced from clinicaltrials.gov