protocolSection identificationModule nctId: NCT06285110, orgStudyIdInfo id: DTG Resist, briefTitle: HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen, acronym: DTG-Resist, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-13, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Bern, class: OTHER, collaborators name: University of Zurich, collaborators name: ETH Zurich, collaborators name: University of KwaZulu, collaborators name: University of Bristol, descriptionModule briefSummary: This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of \>1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure.To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS)., conditionsModule conditions: Hiv, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Type of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen., primaryOutcomes measure: Prevalence of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen., primaryOutcomes measure: Time to virologic failure, primaryOutcomes measure: Number of INSTI DRMs per patient, primaryOutcomes measure: DTG drug resistance, primaryOutcomes measure: Phenotypic resistance levels of novel DRMs, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro Medico Huesped, status: RECRUITING, city: Buenos Aires, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Instituto Nacional de Infectiologia Evandro Chagas - Fiocruz, status: RECRUITING, city: Rio De Janeiro, country: Brazil, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Hopital de Jour du Centre Hospitalier Universitaire (CHU Souro Sanou), status: RECRUITING, city: Bobo-Dioulasso, country: Burkina Faso, geoPoint lat: 11.17715, lon: -4.2979, locations facility: National Centre for HIV/AIDS, Dermatology and STDs (NCHADS), status: RECRUITING, city: Phnom Penh, country: Cambodia, geoPoint lat: 11.56245, lon: 104.91601, locations facility: Regional Hospital Limbe, status: RECRUITING, city: Limbe, country: Cameroon, geoPoint lat: 4.02356, lon: 9.20608, locations facility: Hospital Jamot, status: RECRUITING, city: Yaounde, country: Cameroon, geoPoint lat: 3.86667, lon: 11.51667, locations facility: Centre de Traitement Ambulatoire, status: RECRUITING, city: Brazzaville, country: Congo, geoPoint lat: -4.26613, lon: 15.28318, locations facility: Centre de Traitement Ambulatoire, status: RECRUITING, city: Pointe Noire, country: Congo, geoPoint lat: -4.77609, lon: 11.86352, locations facility: ACONDA Centre de Prise en Charge et de Formation (CePReF), status: RECRUITING, city: Abidjan, country: Côte D'Ivoire, geoPoint lat: 5.30966, lon: -4.01266, locations facility: Centre médical de suivi des donneurs de sang, CNTS, status: RECRUITING, city: Abidjan, country: Côte D'Ivoire, geoPoint lat: 5.30966, lon: -4.01266, locations facility: Moi University, AMPATH, status: RECRUITING, city: Eldoret, country: Kenya, geoPoint lat: 0.52036, lon: 35.26993, locations facility: Lighthouse clinic, status: RECRUITING, city: Lilongwe, country: Malawi, geoPoint lat: -13.96692, lon: 33.78725, locations facility: Martin Preuss Centre, status: RECRUITING, city: Lilongwe, country: Malawi, geoPoint lat: -13.96692, lon: 33.78725, locations facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, status: RECRUITING, city: Mexico City, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Research for Development, Einstein-Rwanda Research and Capacity Building Program, status: RECRUITING, city: Kigali, country: Rwanda, geoPoint lat: -1.94995, lon: 30.05885, locations facility: National Institute for Medical Research (NIMR), status: RECRUITING, city: Kisesa, country: Tanzania, geoPoint lat: -3.08333, lon: 34.15, locations facility: HIV-NAT/Thai Red Cross AIDS Research Center (TRCARC), status: RECRUITING, city: Bangkok, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Ramathibodi Hospital, Mahidol University, status: RECRUITING, city: Bangkok, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Masaka Regional Referral Hospital / AHF Uganda Cares, status: RECRUITING, city: Masaka, country: Uganda, geoPoint lat: -0.33379, lon: 31.73409, locations facility: Mbarara University of Science and Technology / Mbarara ISS Clinic (MUST), status: RECRUITING, city: Mbarara, country: Uganda, geoPoint lat: -0.60467, lon: 30.64851, locations facility: Centre for Infectious Disease Research Zambia (CIDRZ), status: RECRUITING, city: Lusaka, country: Zambia, geoPoint lat: -15.40669, lon: 28.28713, locations facility: Newlands Clinic, status: RECRUITING, city: Harare, country: Zimbabwe, geoPoint lat: -17.82772, lon: 31.05337, hasResults: False