[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467975":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":88,"collaborators":91,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":29,"enrollmentInfo":113,"targetDuration":29,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":49,"whyStopped":29,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","EXPERIMENTAL","In Uganda, participants will be managed per Ministry of Health (MOH) guidelines. GRT is performed by MOH for individuals with virologic failure on TLD. Participants will continue enhanced adherence counseling (EAC) and TLD while awaiting the GRT result. Treatment decision will be made by the regional switch committee when GRT results return. There will be a Week 24 visit for specimen collection.\n\nIn South Africa, participants will be managed per Department of Health (DOH) guidelines. Some individuals will be eligible for GRT (performed by DOH) based on ART duration and adherence per DOH guidelines. Treatment decision will be made by the clinic when GRT results return. Individuals who are ineligible for GRT will undergo EAC and continue on TLD. At Weeks 24, participants will undergo plasma HIV-1 RNA viral load testing. Results will be returned to the clinic team for patient management per DOH guidelines.\n\nAll participants undergo viral load testing at Week 48.",[13],"Other: Standard of Care treatment strategy",{"label":15,"type":10,"description":16,"interventionNames":17},"Individualized Care","Participants will undergo routine EAC, point-of-care urine tenofovir (TFV) testing, and genotypic resistance testing (GRT) at enrollment. Participants will return when GRT results are available for a treatment decision. Side effects and tolerance will also be assessed. All information will be used to make an optimal treatment recommendation with participant input. Participants will have an additional study visit at Week 24 and will continue to have routine care visits, adherence counseling by the clinic, and viral load monitoring at intervals determined by the clinic per national guidelines. Participants will undergo plasma HIV-1 RNA viral load testing at Week 48.",[18],"Other: Individualized Care treatment strategy",{"label":20,"type":10,"description":21,"interventionNames":22},"Immediate Switch","Participants will undergo routine EAC and a switch from TLD to PI-based second-line ART at the enrollment visit (Week 0). Participants will have an additional study visit at Week 24. Participants will continue to have routine care visits and viral load monitoring at intervals determined by the clinic per national guidelines. At study completion, participants will undergo plasma HIV-1 RNA viral load testing at Week 48.",[23],"Other: Immediate Switch",[25,30,34],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Standard of Care treatment strategy","Management of virologic failure on TLD using the Standard of Care strategy",[9],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Individualized Care treatment strategy","Management of virologic failure on TLD using the Individualized Care strategy",[15],{"type":6,"name":20,"description":35,"armGroupLabels":36,"otherNames":29},"Management of virologic failure on TLD using the Immediate Switch strategy",[20],[38],{"name":39,"affiliation":5,"role":40},"Suzanne McCluskey, MD","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":29,"email":45},"CONTACT","617-726-9488","smccluskey@mgh.harvard.edu",[47,66,80],{"facility":48,"status":49,"city":50,"state":29,"zip":29,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RK Khan Hospital Clinic","RECRUITING","Durban","South Africa","ZA",{"type":54,"coordinates":55},"Point",[56,57],31.0292,-29.8579,{"lat":57,"lon":56},[60,62,63],{"name":61,"role":43,"phone":29,"phoneExt":29,"email":29},"Richard Lessells",{"name":61,"role":40,"phone":29,"phoneExt":29,"email":29},{"name":64,"role":65,"phone":29,"phoneExt":29,"email":29},"Mahomed Y Moosa","SUB_INVESTIGATOR",{"facility":67,"status":49,"city":68,"state":29,"zip":29,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Mbarara City Clinic","Mbarara","Uganda","UG",{"type":54,"coordinates":72},[73,74],30.64851,-0.60467,{"lat":74,"lon":73},[77,79],{"name":78,"role":43,"phone":29,"phoneExt":29,"email":29},"Winnie Muyindike",{"name":78,"role":40,"phone":29,"phoneExt":29,"email":29},{"facility":81,"status":49,"city":68,"state":29,"zip":29,"country":69,"countryCode":70,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic",{"type":54,"coordinates":83},[73,74],{"lat":74,"lon":73},[86,87],{"name":78,"role":43,"phone":29,"phoneExt":29,"email":29},{"name":78,"role":40,"phone":29,"phoneExt":29,"email":29},{"type":40,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Suzanne McCluskey","Assistant Professor",[92,94,96,98,101],{"name":93,"class":6},"Mbarara University of Science and Technology",{"name":95,"class":6},"University of KwaZulu",{"name":97,"class":6},"University of California, San Francisco",{"name":99,"class":100},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":102,"class":6},"Bill and Melinda Gates Foundation","100467975","a-randomized-clinical-trial-to-evaluate-solutions-for-the-management-of-virologic-failure-on-tld-in-sub-saharan-africa-100467975",false,"NCT05373758","A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa","A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on Tenofovir, Lamivudine, and Dolutegravir (TLD) in Sub-Saharan Africa","RESOLVE","Inclusion Criteria:\n\n* Age 15 years and above\n* Enrolled in HIV care at one of the study clinics\n* History of two HIV-1 RNA viral load measurements \\>1,000 copies\u002FmL while on TLD\n* On TLD for at least 12 months\n* Lives within 100 kilometers of study clinic\n\n  * Pregnant women are eligible for enrollment.\n\nExclusion Criteria:\n\n* Plans to transfer out of the clinic within the next 48 weeks\n* Plans to move out of the study catchment area within the next 48 weeks\n* As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.","ALL","15 Years",{"count":114,"type":115},648,"ESTIMATED","INTERVENTIONAL",[118],"NA","The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. The primary outcome of interest will be viral suppression to \\\u003C50 copies\u002FmL at 48 weeks using the FDA snapshot definition. The study will be conducted in Uganda and South Africa.",[121,122,123],"HIV Infections","AIDS","Virologic Failure",[125,126,127,128],"ART","Medication Adherence","Drug resistance","Dolutegravir","2026-03-17",{"date":131,"type":132},"2026-03-19","ACTUAL",{"date":134,"type":132},"2024-02-07",{"date":136,"type":115},"2027-06-30",{"name":5,"class":6},3]