[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ain":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100531958","phase-2-artesunate-ointment-for-the-treatment-of-anal-hsil-in-hiv-negative-participants-100531958",false,"NCT06206564","Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants","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)","ART-AIN IIB-2","Inclusion Criteria:\n\n* Adult men and women age ≥ 18 years\n* Capable of informed consent\n* Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.\n* Positive anal human papillomavirus (HPV) test.\n* Women of childbearing potential agree to use birth control for the duration of the study.\n* Laboratory values at Screening of:\n\n  1. Serum alanine transaminase (SGPT\u002FALT) \\\u003C 5 x upper limit of normal (ULN)\n  2. Serum aspartate transaminase (SGOT\u002FAST) \\\u003C 5 x ULN\n  3. Serum Bilirubin (total) \\\u003C 2.5 x ULN\n  4. Serum Creatinine ≤ 1.5 x ULN\n* Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.\n* Weight ≥ 50kg\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA\n* Concurrent anal, vulvar, cervical, or penile cancer\n* HIV-seropositivity\n* Currently receiving systemic chemotherapy or radiation therapy for another cancer.\n* 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.\n* Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors\n* Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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)",[27,28,29,30],"Anal High-grade Squamous Intraepithelial Lesion","Anal HSIL","Anal HPV Infection","AIN",[32,33,34],"intra-anal","topical","non-surgical","RECRUITING","2025-05-14",{"date":38,"type":39},"2025-05-18","ACTUAL",{"date":41,"type":39},"2024-01-12",{"date":43,"type":21},"2026-12-31",{"name":45,"class":46},"Frantz Viral Therapeutics, LLC","INDUSTRY",2]