[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635649":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":66,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Fundação Bahiana de Infectologia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dolutegravir","ACTIVE_COMPARATOR","Dolutegravir 50 mg p.o. daily",[13],"Drug: Dolutegravir (DTG)",{"label":15,"type":16,"description":17,"interventionNames":18},"Combination therapy","EXPERIMENTAL","Daily Dolutegravir 50 mg Daily Tenofovir 300 mg",[19],"Combination Product: Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection","In a previous study Dolutegravir was able to reduce HTLV-1 proviral load, but a few patients did not respond to therapy. We intend to use a combination of Dolutegravir + TDF to improve the response rate. There is no previous evidence on the use of such combination for treating HTLV-1 infection.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Dolutegravir (DTG)","Active comparator will be DTG, 50 mg\u002Fday",[9],[33],{"name":34,"affiliation":35,"role":36},"Carlos Brites, MD, PhD","Hospital Universitário Professor Edgard Santos, Federal University of Bahia","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+5571992329552","crbrites@gmail.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Estela Luz","+5571999867515","eluz5@yahoo.com.br",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hospital Universitário Professor Edgard Santos","RECRUITING","Salvador","Estado de Bahia","40110-060","Brazil","BR",{"type":56,"coordinates":57},"Point",[58,59],-38.49096,-12.97563,{"lat":59,"lon":58},[62,64],{"name":63,"role":39,"phone":44,"phoneExt":26,"email":41},"Estela Luz, PhD",{"name":65,"role":39,"phone":26,"phoneExt":26,"email":26},"Delano Paiva",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Carlos Brites","Full Professor - Infectious Diseases","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":81,"type":82},146,"ESTIMATED","INTERVENTIONAL",[85],"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.",[88,89,90,91],"HTLV-1 Infection","HTLV I Associated Myelopathies","HTLV I Associated T Cell Leukemia Lymphoma","Neuritis",[93,9,94,95,96],"HTLV-1","Tenofovir","Treatment","proviral load","2026-05-29",{"date":99,"type":100},"2026-06-02","ACTUAL",{"date":102,"type":100},"2026-05-07",{"date":104,"type":82},"2028-06",{"name":68,"class":6},1]