Artesunate suppositories for anal HSIL

(anal HSIL HIV- Trial)

Recruiting at 2 trial locations

Overseen By Ahmad Bayat, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Frantz Viral Therapeutics, LLC

Must not be taking: Immunosuppressants, Steroids, UGT inhibitors, others

Disqualifiers: Pregnancy, Cancer, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)

Research Team

Joel Palefsky, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for HIV-negative adults over 18 with a specific type of anal lesion called high-grade squamous intraepithelial lesions (HSIL). They must have normal liver and kidney function, weigh at least 50kg, and women must use birth control. People with low-grade dysplasia only, HIV, other cancers being treated, or on strong immune system suppressants can't join.

Inclusion Criteria

I understand the details of the clinical trial and can give my consent.

I agree to use birth control throughout the study.

I have a confirmed high-grade anal lesion.

Exclusion Criteria

I am HIV positive.

I am using imiquimod or 5-FU during the study.

I have a high-grade precancerous condition in my anal area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four 5-day cycles of artesunate or placebo suppositories at weeks 0, 2, 4, and 6

6 weeks

At least 2 visits (in-person), remaining visits may be virtual

Follow-up

Participants are monitored with anoscopy or high resolution anoscopy (HRA) at weeks 8, 18, 30, and 42. Non-responders at week 18 undergo standard of care ablation

42 weeks

4 visits (in-person)

Extension/Long-term follow-up

Participants who have at least partial response at week 18 are followed with HRA at week 30. Participants with anal HSIL at weeks 30 or 42 are followed according to standard of care procedures

42 weeks

Treatment Details

Interventions

• Artesunate
• Placebo

Trial Overview The study tests Artesunate suppositories against placebo in treating anal HSIL. It's a phase II trial where participants are randomly assigned to either the treatment or placebo group without knowing which one they receive (double-blind).

Participant Groups

Group I: Artesunate suppositories Experimental Treatment 1 Intervention

Four 5-day cycles of artesunate suppositories

Group II: Placebo suppositories Placebo Group 1 Intervention

Four 5-day cycles of placebo suppositories

Artesunate is already approved in United States, European Union for the following indications:

Approved in United States as Artesunate for:

• Malaria
• Cervical intraepithelial neoplasia (CIN2/3) - Investigational

Approved in European Union as Artesunate for:

• Malaria

Who Is Running the Clinical Trial?

Frantz Viral Therapeutics, LLC

Lead Sponsor

Trials

7

Recruited

230+

Anal Dysplasia Clinic MidWest

Collaborator

Trials

2

Recruited

70+

Laser Surgery Care

Collaborator

Trials

3

Recruited

510+

Amarex CRO

Collaborator

Trials

1

Recruited

20+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+