Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants (ART-AIN IIB-2)

February 20, 2024 updated by: Frantz Viral Therapeutics, LLC

A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Ointment for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Recruiting
        • Anal Dysplasia Clinic MidWest
        • Contact:
        • Principal Investigator:
          • Gary Bucher, MD
        • Sub-Investigator:
          • Emily Miller, APN
        • Contact:
          • Agatha Ngwueke
          • Phone Number: 3126232625
    • New York
      • New York, New York, United States, 10011
        • Recruiting
        • Laser Surgery Care
        • Principal Investigator:
          • Joseph Terlizzi, MD
        • Sub-Investigator:
          • Jonathan Baker, PA-C, MPAS
        • Sub-Investigator:
          • Shantice Branch, PA-C
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo ointment
Drug: Placebo
Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6
Other Names:
  • placebo ointment
Experimental: Artesunate
Drug: Artesunate ointment
Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
Other Names:
  • Artemisinin
  • Artesunic acid
  • Dihydroartemisinin (DHA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete and partial response by week 18
Time Frame: 18 weeks
Number of participants with complete and partial response after four 5-day cycles of artesunate ointment
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV clearance
Time Frame: 42 weeks
Number of participants who do not have detectable HPV infection
42 weeks
Complete and partial response after week 18
Time Frame: 30 weeks
Number of participants with complete and partial response after week 18
30 weeks
Complete and partial peri-anal response after intra-anal ointment application
Time Frame: 42 weeks
Number of participants who have complete and partial peri-anal response after 4 5-day cycles of intra-anal ointment
42 weeks
Persistence of response
Time Frame: 42 weeks
Number of participants who have complete response and do not have recurrence of anal HSIL
42 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of intra-anal artesunate ointment
Time Frame: 42 weeks
Number of participants who do not have any drug-related serious adverse events
42 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frantz Viral Therapeutics, LLC

Collaborators

Anal Dysplasia Clinic MidWest
Laser Surgery Care, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-AIN IIB-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No protected health information (PHI) will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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