[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anal-intraepithelial-neoplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anal-intraepithelial-neoplasia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},9,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"Human Papilloma Virus","Human Immunodeficiency Virus","Anal Intraepithelial Neoplasia","High-Grade Squamous Intraepithelial Lesions",[31,32,28],"HIV","HPV","NOT_YET_RECRUITING","2026-05-05",{"date":36,"type":37},"2026-05-08","ACTUAL",{"date":39,"type":20},"2026-06",{"date":41,"type":20},"2027-12",{"name":43,"class":44},"Emory University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":79,"locationsCount":45},"100459767","phase-4-immunogenicity-of-gardasil-9-hpv-vaccine-in-people-living-with-hiv-100459767","NCT05266898","Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV","Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV","AGO-Gard","Inclusion Criteria:\n\n* HIV seropositive\n* immune intact (CD4+ T cell count in peripheral blood \\>200 cells\u002Fml)\n* HIV controlled (peripheral blood HIV viral load \\\u003C1,000 genome copies\u002FmL)\n* Stable on antiretroviral regimen for ≥3 months\n* Gardasil-9 naive and age ≤45 OR\n* documented receipt of 3 doses of Gardasil-4 or Gardasil-9 HPV vaccine\n\nExclusion Criteria:\n\n* Medical contraindication for vaccination (vaccine-naive arm only)\n* Women who are pregnant\n* Acute illness\n* Taking chronic steroids, \\>0.5mg\u002Fkg prednisone or equivalent\n* Taking immune modulating medications\n* Received blood transfusion\u002Fblood products within the past 6 months\n* Recipients of other vaccine products within the past month\n* Inability to provide informed written consent",true,"18 Years","65 Years",{"count":58,"type":20},250,[60],"PHASE4","The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection.\n\nThe secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, and to determine the protection afforded by Gardasil vaccine over time in previously vaccinated adults living with HIV.\n\nThe clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes and continuing protection against vaccine genotypes of HPV over time.",[63,27,64,65,66,28,67],"Papillomavirus Vaccines","Papillomavirus Infection","Serology","Cervical Intraepithelial Neoplasia","Oral Cavity Infection",[69,70,71],"Gardasil-9 HPV vaccine","human papillomavirus","human immunodeficiency virus","RECRUITING","2025-04-15",{"date":75,"type":37},"2025-04-18",{"date":77,"type":37},"2022-11-30",{"date":39,"type":20},{"name":80,"class":44},"Louisiana State University Health Sciences Center in New Orleans"]