[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anal-high-grade-squamous-intraepithelial-lesion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anal-high-grade-squamous-intraepithelial-lesion":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100564211","phase-1-safety-of-anal-curcumin-100564211",false,"NCT06626230","Safety of Anal Curcumin","An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin","Major Inclusion Criteria:\n\n* 30 and older\n* Have biopsy-proven anal intraepithelial neoplasia (AIN) 2, AIN 3 without previous treatment\n* Or cytology results for ASC-H or HSIL\n* Able and willing to complete Study Diary\n* Other inclusion criteria apply\n\nExclusion Criteria:\n\n* Have a clinically significant chronic medical condition that is considered progressive, such as but not limited to coronary disease, congestive heart failure, chronic obstructive lung disease, and diabetes mellitus. Chronic nonprogressive or intermittent syndromes are not excluded, including migraine headaches, mild reactive airway disease, controlled hypertension, stable pain syndromes, or benign gastric reflux.\n* Have any history of anal cancer malignancy.\n* Pregnant or planning to become pregnant in the next three months.\n* Have a history of sensitivity or allergy to any compound used in this study.\n* Have Grade 2 or higher renal or hematology abnormality,\n* Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), recreational drugs, or alcohol abuse.\n* Other exclusion criteria apply",true,"ALL","30 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to see if curcumin can reverse anal high-grade squamous intraepithelial lesions (aHSIL) (high-grade anal precancerous cells or high-grade abnormal cells) in people living with HIV to avoid current treatments such as ablation (destroying abnormal cells with heat or surgical excision (cutting out the abnormal cells)), which have potential short- and long-term side effects.",[27],"Anal High Grade Squamous Intraepithelial Lesion",[29,30,31,32,33,34],"HSIL\u002FAIN 2-3","Curcumin","Cancer","Human Papillomavirus (HPV)","HIV","Curcuminoids","RECRUITING","2026-05-15",{"date":38,"type":39},"2026-05-18","ACTUAL",{"date":41,"type":39},"2025-03-17",{"date":43,"type":21},"2026-07",{"name":45,"class":46},"Lisa Flowers","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100531958","phase-2-artesunate-ointment-for-the-treatment-of-anal-hsil-in-hiv-negative-participants-100531958","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","18 Years",{"count":20,"type":21},[58],"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)",[61,62,63,64],"Anal High-grade Squamous Intraepithelial Lesion","Anal HSIL","Anal HPV Infection","AIN",[66,67,68],"intra-anal","topical","non-surgical","2025-05-14",{"date":71,"type":39},"2025-05-18",{"date":73,"type":39},"2024-01-12",{"date":75,"type":21},"2026-12-31",{"name":77,"class":78},"Frantz Viral Therapeutics, LLC","INDUSTRY"]