[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650292":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":57,"centralContacts":61,"locations":66,"responsibleParty":81,"collaborators":44,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":44,"eligibilityCriteria":88,"healthyVolunteers":85,"sex":89,"minAge":90,"maxAge":44,"enrollmentInfo":91,"targetDuration":44,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":115,"whyStopped":44,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,15,20,25,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate ART + 10-Week Fluconazole Arm Type:","EXPERIMENTAL","Participants eligible for ART timing randomization will initiate antiretroviral therapy immediately at enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy.",[13,14],"Drug: Immediate ART Initiation","Drug: 10-Week Fluconazole",{"label":16,"type":10,"description":17,"interventionNames":18},"Immediate ART + 24-Week Fluconazole","Participants eligible for ART timing randomization will initiate antiretroviral therapy immediately at enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy.",[13,19],"Drug: 24-Week Fluconazole",{"label":21,"type":10,"description":22,"interventionNames":23},"Delayed ART + 10-Week Fluconazole","Participants eligible for ART timing randomization will delay antiretroviral therapy initiation until 14 days after enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy.",[24,14],"Drug: Delayed ART Initiation",{"label":26,"type":27,"description":28,"interventionNames":29},"Delayed ART + 24-Week Fluconazole","ACTIVE_COMPARATOR","Participants eligible for ART timing randomization will delay antiretroviral therapy initiation until 14 days after enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy.",[24,19],{"label":31,"type":10,"description":32,"interventionNames":33},"ART-Experienced + 10-Week Fluconazole","Participants who are already receiving ART or are not eligible for ART timing randomization will continue ART per standard clinical care. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy.",[14],{"label":35,"type":27,"description":36,"interventionNames":37},"ART-Experienced + 24-Week Fluconazole","Participants who are already receiving ART or are not eligible for ART timing randomization will continue ART per standard clinical care. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy.",[19],[39,45,49,53],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Immediate ART Initiation","Antiretroviral therapy will be initiated immediately at enrollment for participants randomized to immediate ART initiation. ART drug choice will be per clinical standard of care.",[9,16],null,{"type":40,"name":46,"description":47,"armGroupLabels":48,"otherNames":44},"Delayed ART Initiation","Antiretroviral therapy will be initiated 14 days after enrollment for participants randomized to delayed ART initiation. ART drug choice will be per clinical standard of care.",[21,26],{"type":40,"name":50,"description":51,"armGroupLabels":52,"otherNames":44},"10-Week Fluconazole","Participants will receive fluconazole 800 mg daily for 14 days, followed by fluconazole 400 mg daily through week 10, then stop fluconazole.",[31,21,9],{"type":40,"name":54,"description":55,"armGroupLabels":56,"otherNames":44},"24-Week Fluconazole","Participants will receive fluconazole 800 mg daily for 14 days, followed by fluconazole 400 mg daily through week 10, then fluconazole 200 mg daily for an additional 14 weeks, for a total fluconazole duration of 24 weeks.",[35,26,16],[58],{"name":59,"affiliation":5,"role":60},"Radha Rajasingham, MD","PRINCIPAL_INVESTIGATOR",[62],{"name":59,"role":63,"phone":64,"phoneExt":44,"email":65},"CONTACT","612-625-4680","radha@umn.edu",[67],{"facility":68,"status":44,"city":69,"state":44,"zip":44,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Infectious Diseases Institute, Makerere University","Kampala","Uganda","UG",{"type":73,"coordinates":74},"Point",[75,76],32.58219,0.31628,{"lat":76,"lon":75},[79,80],{"name":59,"role":63,"phone":64,"phoneExt":44,"email":65},{"name":59,"role":60,"phone":44,"phoneExt":44,"email":44},{"type":82,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100650292","phase-3-optimizing-care-for-cryptococcal-antigenemia-evaluation-of-short-course-fluconazole-and-art-timing-among-crag-persons-with-low-titers-100650292",false,"NCT07743593","Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers","Inclusion Criteria:\n\n* HIV-1 infection\n* Age greater than 18 years\n* Ability and willingness to give informed consent\n* Plasma or serum cryptococcal antigen positive with titer less than 1:160\n\nExclusion Criteria:\n\n* Cannot or unlikely to attend regular clinic visits\n* History of cryptococcal infection\n* Symptomatic meningitis confirmed by cerebrospinal fluid cryptococcal antigen positivity\n* More than 10 weeks of fluconazole therapy\n* Pregnancy confirmed by urinary or serum pregnancy test\n* Current breastfeeding","ALL","18 Years",{"count":92,"type":93},505,"ESTIMATED","INTERVENTIONAL",[96],"PHASE3","This randomized clinical trial will evaluate the optimal duration of fluconazole therapy and timing of antiretroviral therapy initiation among HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda.\n\nParticipants with low-titer cryptococcal antigenemia will be followed to assess whether a shorter 10-week course of fluconazole is non-inferior to the standard 24-week fluconazole regimen for 24-week cryptococcal meningitis-free survival. Among participants eligible for antiretroviral therapy timing randomization, the study will also compare immediate antiretroviral therapy initiation with delayed initiation after 14 days to evaluate 10-week hospitalization-free survival.\n\nParticipants will be followed for up to 24 weeks, with study visits and contacts to assess survival, cryptococcal meningitis, hospitalizations, adverse events, and fluconazole adherence.",[99,100,101,102],"Cryptococcal Antigenemia","HIV-1-infection","Cryptococcal Infection","Cryptococcal Meningitis",[104,105,106,107,108,109,110,111,112,70,113,114],"Cryptococcal antigen","CrAg","Fluconazole","Fluconazole Short-course fluconazole","Low CrAg titer","Immediate ART","Advanced HIV disease","Cryptococcal meningitis-free survival","Hospitalization-free survival","ART initiation","Antiretroviral therapy","NOT_YET_RECRUITING","2026-07-30",{"date":118,"type":119},"2026-08-04","ACTUAL",{"date":121,"type":93},"2026-09-01",{"date":123,"type":93},"2031-08-30",{"name":5,"class":6},1]