{"id":"dolutegravir-sodium-monohydrate","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL3544985","moleculeType":"Small molecule","molecularWeight":"533.58"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Dolutegravir is an integrase strand transfer inhibitor (INSTI) that binds to the catalytic site of HIV integrase and blocks the enzyme's ability to insert viral DNA into the human genome. By preventing integration, the drug halts HIV replication and reduces viral load. This mechanism allows for effective suppression of HIV with a high genetic barrier to resistance.","oneSentence":"Dolutegravir sodium monohydrate inhibits HIV integrase, preventing the virus from integrating its genetic material into the host cell's DNA.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:09:50.099Z","_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 (age-appropriate formulations)"}]},"trialDetails":[{"nctId":"NCT02938520","phase":"PHASE3","title":"Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants","status":"ACTIVE_NOT_RECRUITING","sponsor":"ViiV Healthcare","startDate":"2016-10-27","conditions":"HIV Infections","enrollment":631},{"nctId":"NCT05154747","phase":"PHASE3","title":"Long-Acting Treatment in Adolescents (LATA)","status":"ACTIVE_NOT_RECRUITING","sponsor":"University College, London","startDate":"2023-06-22","conditions":"Hiv, HIV Infections, HIV-1-infection","enrollment":476},{"nctId":"NCT04302896","phase":"EARLY_PHASE1","title":"Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs","status":"COMPLETED","sponsor":"Rhonda Brand","startDate":"2020-08-31","conditions":"Medication Adherence, HIV","enrollment":30},{"nctId":"NCT02028819","phase":"","title":"Compassionate Use of Ibalizumab for the Treatment of HIV Infection","status":"NO_LONGER_AVAILABLE","sponsor":"University of Colorado, Denver","startDate":"2012-01","conditions":"Human Immunodeficiency Virus (HIV)","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["TIVICAY"],"phase":"phase_3","status":"active","brandName":"Dolutegravir Sodium Monohydrate","genericName":"Dolutegravir Sodium Monohydrate","companyName":"University of Colorado, Denver","companyId":"university-of-colorado-denver","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Dolutegravir sodium monohydrate inhibits HIV integrase, preventing the virus from integrating its genetic material into the host cell's DNA. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age-appropriate formulations).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}