NCT06206564 · Frantz Viral Therapeutics, LLC
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
(ART-AIN IIB-2)
What this study is about
This is a phase II double blind, compared against an inactive treatment, randomly assigned study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
View original scientific description
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)
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
Number of participants with complete and partial response after four 5-day cycles of artesunate ointment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. *
Where
- Chicago, Illinois
- New York, New York
Collaborators
Laser Surgery Care, LLC, Anal Dysplasia Clinic MidWest
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2025 · Source of record for eligibility and locations