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Recruiting NCT06206564

Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

Phase II Interventional Anal High-grade Squamous Intraepithelial Lesion Anal HSIL Anal HPV Infection AIN

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artesunate ointment, Placebo.
Who it may be relevant to
Registry conditions: Anal High-grade Squamous Intraepithelial Lesion, Anal HSIL, Anal HPV Infection, AIN. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • Drug Artesunate ointment
    Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
  • Drug Placebo
    Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6

Primary outcome measures

  • Complete and partial response by week 18 [Time frame: 18 weeks]
Secondary outcome measures (4)
  • HPV clearance [Time frame: 42 weeks]
  • Complete and partial response after week 18 [Time frame: 30 weeks]
  • Complete and partial peri-anal response after intra-anal ointment application [Time frame: 42 weeks]
  • Persistence of response [Time frame: 42 weeks]

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:
  • Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN)
  • Serum aspartate transaminase (SGOT/AST) < 5 x ULN
  • Serum Bilirubin (total) < 2.5 x ULN
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Anal Dysplasia Clinic MidWest — Chicago
  • Laser Surgery Care — New York

Identifiers

NCT: NCT06206564 · ART-AIN IIB-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗