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Anti-metabolites

Artesunate for Anal Intraepithelial Lesion (ART-AIN IIB-2 Trial)

Phase 2

Recruiting

Research Sponsored by Frantz Viral Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA

Positive anal human papillomavirus (HPV) test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 weeks

Awards & highlights

ART-AIN IIB-2 Trial Summary

This trial is testing a type of ointment called artesunate on HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL). The study is

Who is the study for?

This trial is for HIV-negative men and women with high-grade squamous lesions in the anal area, which can be precursors to cancer. Participants should not have HPV-related conditions elsewhere like genital warts or cervical lesions.Check my eligibility

What is being tested?

The study tests artesunate ointment against a placebo (inactive substance) to see if it's effective in treating anal HSIL. It's a phase II trial where participants are randomly assigned to receive either the real ointment or placebo without knowing which one they get.See study design

What are the potential side effects?

Specific side effects of artesunate ointment aren't detailed here, but common ones may include local skin reactions like redness, itching, or irritation at the site of application.

ART-AIN IIB-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My biopsy showed high-grade anal precancer.

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I have tested positive for anal HPV.

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I weigh at least 50kg.

ART-AIN IIB-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete and partial response by week 18

Secondary outcome measures

Complete and partial peri-anal response after intra-anal ointment application

Complete and partial response after week 18

HPV clearance

+1 more

Other outcome measures

Safety of intra-anal artesunate ointment

ART-AIN IIB-2 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ArtesunateExperimental Treatment1 Intervention

Group II: Placebo ointmentPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laser Surgery Care, LLCUNKNOWN

Frantz Viral Therapeutics, LLCLead Sponsor

5 Previous Clinical Trials

186 Total Patients Enrolled

Anal Dysplasia Clinic MidWestUNKNOWN

1 Previous Clinical Trials

48 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"According to the current information available on clinicaltrials.gov, this trial is not actively seeking participants. The initial posting date was 1/15/2024, and it was last updated on 1/4/2024. However, there are currently 820 other ongoing trials that are actively recruiting patients at this time."

Answered by AI

What are the potential risks and hazards associated with the usage of Artesunate in individuals?

"Based on the information provided, our team at Power rates the safety of Artesunate as a 2. This assessment is made because this trial is classified as Phase 2, indicating that there is some available data supporting its safety but no evidence yet supporting its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06206564.

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