Active — Not RecruitingPhase 2

Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL

United States17 participantsStarted 2023-02-10

Plain-language summary

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)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Number of subjects with complete and partial response by week 18

Timeframe: 18 weeks

Trial details

NCT IDNCT05555862

SponsorFrantz Viral Therapeutics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-28

View on ClinicalTrials.gov More Anal High Grade Squamous Intraepithelial Lesion trials