[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534015":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":77,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":31,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":31,"enrollmentInfo":92,"targetDuration":31,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":107,"whyStopped":31,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Emory University","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Level 1","EXPERIMENTAL","Initial three study participants will be enrolled in Dose Level 1, 2.5% ACU-D1 twice daily for 4 weeks.",[13,14],"Drug: Dose Level 1 ACU-D1 ointment","Procedure: Vulvar\u002F Perianal Biopsy",{"label":16,"type":10,"description":17,"interventionNames":18},"Level 2","If there are no DLTs to Dose Level 1 then, 3 new study participants will proceed to Dose Level 2 at 5% ACU-D1.",[19,14],"Drug: Dose Level 2 ACU-D1 ointment",{"label":21,"type":10,"description":22,"interventionNames":23},"Level 3","If there are no DLTs to Dose Level 2 then, 3 new study participants will proceed to Dose Level 3 at 10 % ACU-D1.",[24,14],"Drug: Dose Level 3 ACU-D1 ointment",[26,32,36,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Dose Level 1 ACU-D1 ointment","ACU-D1 is a topical therapeutic agent that has pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate) (PTTC) as its major active ingredient. PTTC is a novel proteasome inhibitor that has antiangiogenic and anti-inflammatory activities that reduce pro-inflammatory cytokines. ACU-D1 ointment contains a range of 2.5% to 10% weight by volume of PTTC.\n\nLevel 1 will consist of 2.5% ACU-D1 ointment, used twice daily for 4 weeks.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Dose Level 2 ACU-D1 ointment","Level 2 will consist of 5% ACU-D1 ointment, used twice daily for 4 weeks.",[16],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Dose Level 3 ACU-D1 ointment","Level 3 will consist of 10% ACU-D1 ointment, used twice daily for 4 weeks.",[21],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"PROCEDURE","Vulvar\u002F Perianal Biopsy","3 vulvar or perianal biopsies are to be performed at the screening as well as at the end of the study (week 4).",[9,16,21],[46],{"name":47,"affiliation":5,"role":48},"Lisa Flowers, MD, MPH","PRINCIPAL_INVESTIGATOR",[50,54],{"name":47,"role":51,"phone":52,"phoneExt":31,"email":53},"CONTACT","678-596-3554","Lflowe2@emory.edu",{"name":55,"role":51,"phone":56,"phoneExt":31,"email":57},"Nadine Campbell, MD","404-251-8794","nadine.campbell@emory.edu",[59],{"facility":60,"status":31,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Grady Memorial Hospital","Atlanta","Georgia","30303","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-84.38798,33.749,{"lat":70,"lon":69},[73],{"name":74,"role":51,"phone":75,"phoneExt":31,"email":76},"Lisa Flowers, MD","404-251-8931","lflowe2@emory.edu",{"type":48,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Lisa Flowers","Professor",[81],{"name":82,"class":6},"Georgia Center for Oncology Research & Education","100534015","phase-1-use-of-acu-d1-in-hpv-associated-vulvar-and-perianal-lesions-in-people-with-hiv-100534015",false,"NCT06233331","Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV","Phase I Dose Escalation Study of the Use of ACU-D1, a Topical Proteasome Inhibitor in HPV Associated Vulvar and Perianal Lesions in People With HIV","Inclusion Criteria:\n\n* Age 21 years and older\n* HIV-infected\n* Able to provide informed consent\n* Biopsy-proven HSIL disease of the vulvar and perianal region with a total disease volume of 3 cm or greater\n* Combined antiretrovirals (cART) adherence\n* CD4 count \\> 200 cells\u002Fml\n* Sustained undetectable viral load for ≥ 3 months\n* If applicable, on reliable birth control such as combined oral contraceptive pills (OCP), bilateral tubal ligation (BTL), a long-acting reversible contraceptive, or Depo-Provera (birth control shot)\n* Willingness to conform to study requirements\n* Reliable follow-up and contact information\n* No risk factors or clinical suspicion for micro-invasive disease and absence of medical condition that interferes with the conduct of the study in the investigator's opinion\n\nExclusion Criteria:\n\n* Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating","ALL","21 Years",{"count":93,"type":94},9,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are:\n\n* The maximum tolerated dose of ACU-D1\n* Safety and tolerability of topical ACU-D1\n* Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions\n* Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals\n\nParticipants will be asked\n\n* To apply ACU-D1 on the lesions twice daily for 4 weeks\n* 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.",[100,101,102,103],"Human Papilloma Virus","Human Immunodeficiency Virus","Anal Intraepithelial Neoplasia","High-Grade Squamous Intraepithelial Lesions",[105,106,102],"HIV","HPV","NOT_YET_RECRUITING","2026-05-05",{"date":110,"type":111},"2026-05-08","ACTUAL",{"date":113,"type":94},"2026-06",{"date":115,"type":94},"2027-12",{"name":5,"class":6},1]