[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opportunistic-infections-hiv-related\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opportunistic-infections-hiv-related":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100639501","enhanced-treatment-strategy-for-disseminated-mac-infection-in-hiv-patients-a-randomized-controlled-trial-100639501",false,"NCT07585461","Enhanced Treatment Strategy for Disseminated MAC Infection in HIV Patients: A Randomized Controlled Trial","A Multicenter, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Adding Fluoroquinolone (Levofloxacin or Moxifloxacin) to Standard Triple Therapy in Disseminated Mycobacterium Avium Complex Infection","Inclusion Criteria:\n\n* Age ≥18 years\n* HIV infection confirmed\n* Disseminated Mycobacterium avium complex (MAC) infection confirmed by positive culture from a sterile site or positive molecular\u002Fsequencing-based detection from a sterile site specimen considered clinically significant\n* Systemic manifestations consistent with disseminated infection\n* Planned initiation of standard antimycobacterial therapy\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Prior effective antimycobacterial treatment for \\>14 days before enrollment\n* Known macrolide resistance, if susceptibility data are available\n* Hypersensitivity to macrolides, ethambutol, rifamycins, or fluoroquinolones\n* Baseline QTc \\>500 ms or history of significant cardiac arrhythmia\n* Uncorrected hypokalemia or hypomagnesemia\n* History of severe adverse reaction to fluoroquinolones, such as tendon rupture or severe neuropathy\n* Severe hepatic impairment or severe renal dysfunction precluding study treatment\n* Concomitant medications that significantly prolong QT interval and cannot be safely discontinued\n* Pregnancy or breastfeeding\n* Coexisting infection requiring non-protocol antimycobacterial therapy, such as active tuberculosis\n* Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results","ALL","18 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"NA","Background:\n\nDisseminated Mycobacterium avium complex (MAC) infection remains a serious opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression. Despite the widespread use of antiretroviral therapy (ART), disseminated MAC (DMAC) continues to be associated with significant morbidity and mortality. The current standard treatment consists of a macrolide-based triple regimen, including a macrolide, ethambutol, and rifamycin. However, in patients with high mycobacterial burden or profound immunodeficiency, early microbiological response and clinical improvement are often suboptimal, and treatment is complicated by drug interactions and tolerability issues.\n\nObjective:\n\nThis study aims to evaluate whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to the standard triple therapy improves early clinical outcomes in HIV-infected patients with disseminated MAC infection.\n\nMethods:\n\nThis is a prospective, multicenter, randomized, open-label, controlled trial. A total of 124 adult HIV-infected patients with confirmed disseminated MAC infection will be randomly assigned in a 1:1 ratio to receive either standard triple therapy (macrolide, ethambutol, and rifamycin) or an intensified four-drug regimen with the addition of a fluoroquinolone during the initial 8-week intensive phase. Participants will be followed for at least 24 weeks.\n\nOutcomes:\n\nThe primary endpoint is the clinical symptom resolution rate at Day 28. Secondary endpoints include microbiological outcomes (culture or molecular conversion at Days 28, 56, and 84), time to culture conversion, mortality, relapse, and safety outcomes including adverse events and QT interval prolongation.\n\nSignificance:\n\nThis study will provide prospective evidence on whether an intensified treatment strategy can improve early clinical response and microbiological clearance in disseminated MAC infection, while maintaining an acceptable safety profile. The findings may help optimize treatment strategies for HIV-associated disseminated MAC infection.",[26,27],"Opportunistic Infections, HIV Related","Disseminated Mycobacterium Avium Complex Infection",[29,30,31],"Disseminated MAC","HIV","Fluoroquinolone","NOT_YET_RECRUITING","2026-05-08",{"date":35,"type":36},"2026-05-13","ACTUAL",{"date":38,"type":20},"2026-04-30",{"date":40,"type":20},"2028-12-31",{"name":42,"class":43},"Shanghai Public Health Clinical Center","OTHER_GOV",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100633413","real-world-cohort-study-of-antiretroviral-therapy-in-hiv-patients-with-opportunistic-infections-100633413","NCT07526363","Real-world Cohort Study of Antiretroviral Therapy in HIV Patients With Opportunistic Infections","Inclusion Criteria:\n\n* For the opportunistic infection treatment group: Inclusion criteria: a) Age ≥ 18 years, diagnosed with HIV-1 infection; b) Clinically diagnosed with one of the following opportunistic infections and initiating anti-infective therapy: PCP, tuberculosis, NTM infection, CMV infection, herpes simplex virus and varicella-zoster virus infection, toxoplasmosis encephalopathy, oral fungal infection, cryptococcal meningitis, Marneffei basket disease, PML; c) Intending to initiate ART therapy or currently receiving ART therapy; d) The individual (or their legal representative) voluntarily signs a written informed consent form.\n* For the non-opportunistic infection group: a) Age ≥ 18 years, diagnosed with HIV-1 infection; b) Intending to start ART treatment or currently receiving ART treatment; c) The individual (or legal representative) voluntarily signs a written informed consent form.\n\nExclusion Criteria:\n\n* For the opportunistic infection treatment group: Exclusion criteria: a) Individuals suffering from major neurological or psychiatric illnesses such as schizophrenia, epilepsy, or severe depression; b) Individuals with a history of drug use or recent history of alcohol or drug dependence; c) Individuals deemed unsuitable for participation by researchers, such as those in the acute phase of severe cardiovascular disease; d) Individuals deemed unsuitable for participation by other researchers; e) Individuals whose long-term follow-up requirements and frequency cannot be guaranteed.\n* For the non-opportunistic infection group: a) Individuals with coexisting opportunistic infections; b) Individuals suffering from major neurological or psychiatric illnesses such as schizophrenia, epilepsy, or severe depression; c) Individuals with a history of drug use or recent history of alcohol or drug dependence; d) Individuals deemed unsuitable for participation by researchers, such as those in the acute phase of severe cardiovascular disease; e) Individuals deemed unsuitable for participation by other researchers; f) Individuals whose long-term follow-up requirements and frequency cannot be guaranteed.",{"count":51,"type":20},8000,"30 Months","OBSERVATIONAL","This study stratified and compared the differences in virological efficacy and sustained viral suppression status between HIV-infected patients with and without opportunistic infections, providing a basis for optimizing antiretroviral therapy for opportunistic infections and a data foundation for establishing predictive models.",[26],"2026-04-06",{"date":58,"type":36},"2026-04-13",{"date":60,"type":20},"2026-05-01",{"date":62,"type":20},"2029-06-01",{"name":42,"class":43}]