[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Carlos Brites\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100635649","phase-2-dolutegravir-versus-dolutegravir-in-combination-with-tenofovir-for-the-treatment-of-htlv-1-infection-100635649",false,"NCT07555431","Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection","Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection (DOT-H): an Open-label, Randomized, Controlled Study.","DOT-H","Inclusion Criteria:\n\n* Age equal or higher than 18 years\n* Confirmed HTLV-1 infection\n* Clinical manifestation atributable to HTLV-1\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Active HIV, HCV (RNA+), or HBV (HBsAg+) infection\n* Active tuberculosis\n* Recent corticosteroid use\n* Renal impairment (CrCl \\\u003C50 mL\u002Fmin)\n* Autoimmune diseases\n* Wheelchair-bound individuals\n* Active malignancy (except ATLL)\n* Substance abuse interfering with adherence\n* Any condition compromising safety","ALL","18 Years",{"count":20,"type":21},146,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase 2b, open-label, randomized controlled trial evaluates the efficacy and safety of dolutegravir (DTG) alone versus dolutegravir combined with tenofovir disoproxil fumarate (TDF) in individuals with HTLV-1 infection and associated clinical manifestations. The primary objective is to compare changes in HTLV-1 proviral load at 24 and 48 weeks. Secondary outcomes include clinical, functional, immunological, and quality-of-life measures.",[27,28,29,30],"HTLV-1 Infection","HTLV I Associated Myelopathies","HTLV I Associated T Cell Leukemia Lymphoma","Neuritis",[32,33,34,35,36],"HTLV-1","Dolutegravir","Tenofovir","Treatment","proviral load","RECRUITING","2026-05-29",{"date":40,"type":41},"2026-06-02","ACTUAL",{"date":43,"type":41},"2026-05-07",{"date":45,"type":21},"2028-06",{"name":47,"class":48},"Carlos Brites","OTHER",""]