{"id":"dolutegravir-lamivudine-pill","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This combination tablet contains two antiretroviral agents with complementary mechanisms. Dolutegravir is an integrase strand transfer inhibitor (INSTI) that blocks the enzyme responsible for inserting viral DNA into human chromosomes. Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that terminates the viral reverse transcription process. Together, they provide dual suppression of HIV replication at different stages of the viral lifecycle.","oneSentence":"Dolutegravir inhibits HIV integrase to prevent viral DNA integration into the host genome, while lamivudine inhibits reverse transcriptase to block HIV replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:35:27.933Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection in treatment-naïve and treatment-experienced adults"},{"name":"HIV-1 infection in adolescents and children (weight-based dosing)"}]},"trialDetails":[{"nctId":"NCT06967753","phase":"PHASE4","title":"Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)","status":"RECRUITING","sponsor":"UBATEC","startDate":"2025-07-31","conditions":"HIV, HIV-1","enrollment":50},{"nctId":"NCT06444620","phase":"PHASE3","title":"B/F/TAF to DTG/3TC Switch Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Nairobi","startDate":"2024-07-22","conditions":"HIV-1-infection","enrollment":240},{"nctId":"NCT04880395","phase":"PHASE4","title":"Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3","status":"COMPLETED","sponsor":"Fundación Huésped","startDate":"2021-05-17","conditions":"HIV-1-infection","enrollment":265},{"nctId":"NCT04884139","phase":"PHASE4","title":"DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:","status":"COMPLETED","sponsor":"Fundacion SEIMC-GESIDA","startDate":"2021-07-14","conditions":"HIV-1-infection","enrollment":554},{"nctId":"NCT06774872","phase":"PHASE2","title":"Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully","status":"RECRUITING","sponsor":"Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida","startDate":"2025-04-30","conditions":"HIV-1-infection","enrollment":408},{"nctId":"NCT04707326","phase":"","title":"Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Erasmus Medical Center","startDate":"2019-11-01","conditions":"Hiv","enrollment":2040},{"nctId":"NCT04585737","phase":"PHASE4","title":"Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF","status":"COMPLETED","sponsor":"Charlotte-Paige Rolle, MD","startDate":"2020-10-05","conditions":"HIV I Infection","enrollment":222},{"nctId":"NCT04549467","phase":"PHASE4","title":"Efficacy of Dolutegravir Plus Lamivudine in HIV-1-infected Treatment-naïve Adults Without a Baseline Genotyping Test","status":"COMPLETED","sponsor":"Fundacion IDEAA","startDate":"2020-11-17","conditions":"Hiv, HIV-1-infection","enrollment":244},{"nctId":"NCT04808973","phase":"PHASE3","title":"DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women","status":"COMPLETED","sponsor":"Fundação Bahiana de Infectologia","startDate":"2021-07-01","conditions":"HIV Infections, Pregnancy Related, Mother to Child Transmission","enrollment":20},{"nctId":"NCT05735535","phase":"PHASE3","title":"Women in Dual With Dolutegravir","status":"UNKNOWN","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2023-10-01","conditions":"HIV Infections","enrollment":290},{"nctId":"NCT02588820","phase":"PHASE3","title":"Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection","status":"UNKNOWN","sponsor":"David Garcia Cinca","startDate":"2016-04","conditions":"HIV Infections","enrollment":15}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":29,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Dovato"],"phase":"marketed","status":"active","brandName":"Dolutegravir / Lamivudine Pill","genericName":"Dolutegravir / Lamivudine Pill","companyName":"Charlotte-Paige Rolle, MD","companyId":"charlotte-paige-rolle-md","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Dolutegravir inhibits HIV integrase to prevent viral DNA integration into the host genome, while lamivudine inhibits reverse transcriptase to block HIV replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (weight-based dosing).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}