[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-herpes-simplex\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-herpes-simplex":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100619189","phase-4-prevention-of-recurrence-of-herpes-simplex-in-autoimmune-rheumatic-diseases-100619189",false,"NCT07341386","Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases","Prevention of Recurrence of Herpes Simplex in Patients With Autoimmune Rheumatic Diseases","PRoHerpARD","Inclusion Criteria\n\n* Eligible participants must be \\>12 years old\n* Any sex\n* Have a confirmed diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted classification criteria, including: rheumatoid arthritis (ACR\u002FEULAR 2010), juvenile idiopathic arthritis (ILAR), axial spondyloarthritis (ASAS 2009), psoriatic arthritis (CASPAR 2012), systemic lupus erythematosus (SLICC 2012), systemic sclerosis (ACR 2013), dermatomyositis\u002Fpolymyositis (Bohan \\& Peter), systemic vasculitis (Takayasu arteritis, granulomatosis with polyangiitis, polyarteritis nodosa), primary Sjögren's syndrome (ACR\u002FEULAR 2016), mixed connective tissue disease (Alarcón-Segovia or Kasukawa criteria), chronic recurrent multifocal osteomyelitis (Jansson et al., 2007), sarcoidosis (ATS\u002FERS\u002FWASOG 2020 statement) and behçet's syndrome (International Study Group, 1990).\n* Present serologic evidence of prior HSV infection (complement fixation titer ≥ 1:8)\n* A clinical history of recurrent oral or genital herpes simplex virus infection, defined as at least four episodes in the past 12 months.\n\nExclusion Criteria\n\n-Participants will be excluded if they have a known hypersensitivity to acyclovir or any component of the study medication.","ALL","12 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate the effectiveness and safety of oral suppressive therapy with acyclovir in preventing herpes simplex virus (HSV) reactivation in patients with autoimmune rheumatic diseases (ARDs) who have a history of recurrent HS episodes.\n\nThe main questions this study aims to answer are:\n\nDoes continuous oral acyclovir reduce the frequency of HSV reactivation in ARD patients compared to placebo? What is the safety profile of prolonged acyclovir use in this population? What are the main risk factors (clinical and treatment-related) associated with HSV reactivation in immunosuppressed patients.\n\nParticipants will:\n\nBe randomly assigned (1:1) to receive oral acyclovir (400 mg BID) or placebo for 12 months; Be followed for a total of 24 months, with regular clinical evaluations (every 3 months) and laboratory monitoring (every 3 months); Be assessed for HSV recurrence based on clinical symptoms, detection of HSV DNA by polymerase chain reaction (PCR) in mucocutaneous swabs in doubtful cases, and standardized reporting forms; Undergo disease activity assessments and adverse event monitoring at regular intervals.\n\nThe study includes adult and pediatric patients with confirmed diagnoses of one of the following ARDs: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), dermatomyositis\u002Fpolymyositis (DM\u002FPM), systemic sclerosis (SSc), systemic vasculitis, primary Sjögren's syndrome, Mixed connective tissue disease (MCTD), Chronic recurrent multifocal osteomyelitis (CRMO), Sarcoidosis and Behçet's Syndrome. All participants must have a documented history of recurrent HSV (oral and\u002For genital) before inclusion.",[27,28,29],"Autoimmune Rheumatic Diseases","Recurrent Herpes Simplex","Prevention",[31,32,27,33,34,35,36],"Herpes Simplex Virus","Acyclovir","Rheumatology","Pediatric Rheumatology","Antiviral Suppressive Therapy","Infectious Disease Prevention","NOT_YET_RECRUITING","2026-03-03",{"date":40,"type":41},"2026-03-05","ACTUAL",{"date":43,"type":21},"2026-04-01",{"date":45,"type":21},"2028-04-01",{"name":47,"class":48},"University of Sao Paulo General Hospital","OTHER"]