{"id":"placebo-to-bic-ftc-taf","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Abnormal liver function tests"}]},"_chembl":{"chemblId":"CHEMBL6068498","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bictegravir (BIC) is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing viral DNA integration into the host genome. Emtricitabine (FTC) and tenofovir alafenamide (TAF) are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs) that inhibit reverse transcriptase, blocking conversion of viral RNA to DNA. Together, these three agents provide complementary mechanisms to suppress HIV replication.","oneSentence":"BIC/FTC/TAF is a fixed-dose combination of three antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:28:33.929Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection in treatment-naïve adults"},{"name":"HIV-1 infection in treatment-experienced adults (as part of combination antiretroviral therapy)"}]},"trialDetails":[{"nctId":"NCT07266831","phase":"PHASE2, PHASE3","title":"A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-12-18","conditions":"Human Immunodeficiency Virus Type 1 (HIV-1) Infection","enrollment":570},{"nctId":"NCT04223791","phase":"PHASE3","title":"Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-02-18","conditions":"HIV Infection","enrollment":643},{"nctId":"NCT04233879","phase":"PHASE3","title":"Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-02-28","conditions":"HIV-1 Infection","enrollment":599},{"nctId":"NCT04564547","phase":"PHASE2","title":"Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2021-03-09","conditions":"HIV-1 Infection","enrollment":161},{"nctId":"NCT05630755","phase":"PHASE3","title":"A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2023-02-17","conditions":"HIV-1 Infection","enrollment":514},{"nctId":"NCT06333808","phase":"PHASE3","title":"Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Gilead Sciences","startDate":"2024-03-25","conditions":"HIV-1-infection","enrollment":577},{"nctId":"NCT05705349","phase":"PHASE3","title":"DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2023-03-08","conditions":"HIV-1 Infection","enrollment":537},{"nctId":"NCT05549180","phase":"PHASE4","title":"Phase IV, a Clinical Trial to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric Vulnerabilities","status":"COMPLETED","sponsor":"Fundacion SEIMC-GESIDA","startDate":"2022-10-06","conditions":"HIV Infections","enrollment":84},{"nctId":"NCT02397694","phase":"PHASE2","title":"Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-03-23","conditions":"HIV-1 Infection","enrollment":98}],"_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":[],"phase":"phase_3","status":"active","brandName":"Placebo to BIC/FTC/TAF","genericName":"Placebo to BIC/FTC/TAF","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BIC/FTC/TAF is a fixed-dose combination of three antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication. Used for HIV-1 infection in treatment-naïve adults, HIV-1 infection in treatment-experienced adults (as part of combination antiretroviral therapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}