Trial Title:
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
NCT ID:
NCT06206564
Condition:
Anal High-grade Squamous Intraepithelial Lesion
Anal HSIL
Anal HPV Infection
Conditions: Official terms:
Papillomavirus Infections
Squamous Intraepithelial Lesions of the Cervix
Carcinoma, Squamous Cell
Carcinoma in Situ
Artesunate
Artenimol
Artemisinins
Artemisinin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Double blind, placebo-controlled randomized trial
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
Double-blind, placebo-controlled
Intervention:
Intervention type:
Drug
Intervention name:
Artesunate ointment
Description:
Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
Arm group label:
Artesunate
Other name:
Artesunic acid
Other name:
Dihydroartemisinin (DHA)
Other name:
Artemisinin
Intervention type:
Drug
Intervention name:
Placebo
Description:
Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6
Arm group label:
Placebo ointment
Other name:
placebo ointment
Summary:
This is a phase II double blind, placebo-controlled, randomized study of artesunate
ointment for the treatment of HIV-negative men and women who have anal high grade
squamous intraepithelial lesions (anal HSIL)
Detailed description:
Eligible participants in this study are randomized 2:1 to receive either artesunate or
placebo ointment for the treatment of anal HSIL. Both groups receive four 5-day cycles of
ointment, at weeks 0, 2, 4, and 6. Participants are followed closely with anoscopy or
high resolution anoscopy (HRA) at weeks 8, 18, 30, and 42. After the week 18 HRA visit,
participants who have at least partial response will be followed with HRA at week 30.
Participants who are found to be non-responders at week 18 will undergo standard of care
ablation.
Participants who are found to have anal HSIL at weeks 30 or 42 will be followed according
to standard of care procedures.
Primary Objective: To evaluate the complete and partial histopathologic response to four
5-day cycles of artesunate ointment in adult patients with biopsy-proven HPV-associated
intra-anal HSIL (18 weeks).
Secondary Objectives:
Efficacy:
To evaluate the viral clearance after four 5-day cycles of artesunate ointment To
evaluate complete and partial intra-anal response To evaluate complete and partial
peri-anal response To evaluate persistence of response throughout the study window
Safety:
To evaluate the safety of artesunate ointment for the treatment of intra-anal HSIL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult men and women age ≥ 18 years
- Capable of informed consent
- Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.
- Positive anal human papillomavirus (HPV) test.
- Women of childbearing potential agree to use birth control for the duration of the
study.
- Laboratory values at Screening of:
1. Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN)
2. Serum aspartate transaminase (SGOT/AST) < 5 x ULN
3. Serum Bilirubin (total) < 2.5 x ULN
4. Serum Creatinine ≤ 1.5 x ULN
- Electrocardiogram (ECG) with no clinically significant findings as assessed by the
Investigator.
- Weight ≥ 50kg
Exclusion Criteria:
- Pregnant and nursing women
- Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant
diagnosis of anal HSIL, by HRA
- Concurrent anal, vulvar, cervical, or penile cancer
- HIV-seropositivity
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- Patients who are on medical treatment with systemic immunosuppressants or steroids
(e.g., active autoimmune disease). Participants using nasal steroid treatments for
allergic conditions may participate in the study.
- Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase)
inhibitors
- Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anal Dysplasia Clinic MidWest
Address:
City:
Chicago
Zip:
60614
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gary Bucher, MD
Phone:
312-623-2625
Email:
garybuchermd@adcmidwest.com
Contact backup:
Last name:
Agatha Ngwueke
Phone:
3126232625
Investigator:
Last name:
Gary Bucher, MD
Email:
Principal Investigator
Investigator:
Last name:
Emily Miller, APN
Email:
Sub-Investigator
Facility:
Name:
Laser Surgery Care
Address:
City:
New York
Zip:
10011
Country:
United States
Status:
Recruiting
Contact:
Last name:
Taylor Ridley
Phone:
212-242-6500
Email:
tridley@lasersurgerycare.com
Investigator:
Last name:
Joseph Terlizzi, MD
Email:
Principal Investigator
Investigator:
Last name:
Jonathan Baker, PA-C, MPAS
Email:
Sub-Investigator
Investigator:
Last name:
Shantice Branch, PA-C
Email:
Sub-Investigator
Start date:
January 12, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Frantz Viral Therapeutics, LLC
Agency class:
Industry
Collaborator:
Agency:
Laser Surgery Care, LLC
Agency class:
Other
Collaborator:
Agency:
Anal Dysplasia Clinic MidWest
Agency class:
Other
Source:
Frantz Viral Therapeutics, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06206564
