{"id":"darunavir-cobicistat-fdc","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Diarrhea"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Headache"},{"rate":"3-7","effect":"Rash"},{"rate":"3-5","effect":"Abdominal pain"},{"rate":"5-10","effect":"Elevated liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL2095208","moleculeType":"Small molecule","molecularWeight":"776.04"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Darunavir binds to and inhibits HIV protease, preventing the cleavage of viral polyproteins necessary for infectious particle maturation. Cobicistat acts as a pharmacokinetic booster by inhibiting cytochrome P450 3A4, significantly increasing darunavir plasma concentrations and allowing for lower, more convenient dosing. Together, they provide enhanced antiretroviral activity against HIV-1.","oneSentence":"Darunavir is a protease inhibitor that blocks HIV protease to prevent viral replication, while cobicistat is a boosting agent that inhibits CYP3A4 to increase darunavir levels.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:32:09.502Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection in treatment-naïve and treatment-experienced adults"},{"name":"HIV-1 infection in combination with other antiretroviral agents"}]},"trialDetails":[{"nctId":"NCT06337032","phase":"PHASE4","title":"A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments","status":"RECRUITING","sponsor":"Gilead Sciences","startDate":"2024-08-27","conditions":"HIV-1-infection","enrollment":350},{"nctId":"NCT06787976","phase":"PHASE4","title":"Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.","status":"NOT_YET_RECRUITING","sponsor":"Instituto Mexicano del Seguro Social","startDate":"2025-06-19","conditions":"HIV, Insomnia, Anxiety","enrollment":140},{"nctId":"NCT04442737","phase":"PHASE4","title":"A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain","status":"COMPLETED","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2020-07-01","conditions":"HIV-1","enrollment":103},{"nctId":"NCT03123848","phase":"PHASE4","title":"A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2017-04-14","conditions":"Healthy","enrollment":8},{"nctId":"NCT03227861","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care","status":"COMPLETED","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2017-07-31","conditions":"HIV-1","enrollment":109},{"nctId":"NCT02578550","phase":"PHASE1","title":"A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants","status":"COMPLETED","sponsor":"Janssen Sciences Ireland UC","startDate":"2015-11","conditions":"Healthy","enrollment":126},{"nctId":"NCT04718805","phase":"PHASE1","title":"A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2021-01-26","conditions":"Healthy","enrollment":22},{"nctId":"NCT04661397","phase":"PHASE1","title":"A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2021-01-05","conditions":"Healthy","enrollment":37},{"nctId":"NCT02984852","phase":"PHASE1","title":"Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants","status":"COMPLETED","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2016-12","conditions":"Healthy","enrollment":30},{"nctId":"NCT04208061","phase":"PHASE1","title":"A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2019-12-18","conditions":"Healthy","enrollment":28},{"nctId":"NCT03577470","phase":"","title":"An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate","status":"COMPLETED","sponsor":"Janssen-Cilag S.p.A.","startDate":"2018-06-13","conditions":"Human Immunodeficiency Virus (HIV)","enrollment":246},{"nctId":"NCT04388904","phase":"PHASE4","title":"Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)","status":"COMPLETED","sponsor":"The Crofoot Research Center, Inc.","startDate":"2021-09-01","conditions":"HIV-1-infection","enrollment":75},{"nctId":"NCT05197075","phase":"PHASE1","title":"A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2022-08-03","conditions":"Human Immunodeficiency Virus (HIV)","enrollment":15},{"nctId":"NCT04040075","phase":"PHASE4","title":"Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy","status":"TERMINATED","sponsor":"Southampton Healthcare, Inc.","startDate":"2019-07-01","conditions":"HIV-1-infection","enrollment":12},{"nctId":"NCT05378906","phase":"PHASE1","title":"A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2022-06-07","conditions":"Healthy","enrollment":32},{"nctId":"NCT02431247","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects","status":"COMPLETED","sponsor":"Janssen Sciences Ireland UC","startDate":"2015-07-06","conditions":"Immunodeficiency Virus Type 1, Human","enrollment":725},{"nctId":"NCT02269917","phase":"PHASE3","title":"Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants","status":"COMPLETED","sponsor":"Janssen R&D Ireland","startDate":"2015-03","conditions":"Human Immunodeficiency Virus Type 1","enrollment":1149},{"nctId":"NCT03631732","phase":"PHASE3","title":"Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2018-08-28","conditions":"HIV-1 Infection","enrollment":496},{"nctId":"NCT04006704","phase":"PHASE1","title":"Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets","status":"COMPLETED","sponsor":"Janssen Pharmaceutica N.V., Belgium","startDate":"2019-10-10","conditions":"HIV-1","enrollment":25},{"nctId":"NCT02603107","phase":"PHASE3","title":"Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-11-20","conditions":"HIV-1 Infection","enrollment":578},{"nctId":"NCT02616029","phase":"PHASE3","title":"Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-12-17","conditions":"HIV-1 Infection","enrollment":66},{"nctId":"NCT04236453","phase":"PHASE1","title":"A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents","status":"TERMINATED","sponsor":"Janssen Pharmaceutica N.V., Belgium","startDate":"2020-01-23","conditions":"Healthy","enrollment":16},{"nctId":"NCT02616783","phase":"PHASE3","title":"Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-12-22","conditions":"HIV-1 Infection","enrollment":167},{"nctId":"NCT02469246","phase":"PHASE3","title":"Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-06-29","conditions":"HIV-1 Infection","enrollment":567},{"nctId":"NCT02993237","phase":"PHASE1","title":"Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2017-01-23","conditions":"HIV-1","enrollment":27},{"nctId":"NCT01497899","phase":"PHASE2","title":"Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2011-12-28","conditions":"Acquired Immunodeficiency Syndrome, HIV Infections","enrollment":279},{"nctId":"NCT01968551","phase":"PHASE3","title":"Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2013-09-03","conditions":"HIV-1, HIV Infections, Acquired Immunodeficiency Syndrome","enrollment":158},{"nctId":"NCT02605954","phase":"PHASE3","title":"Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-11-18","conditions":"HIV-1 Infection","enrollment":275},{"nctId":"NCT00855335","phase":"PHASE3","title":"A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women","status":"COMPLETED","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2009-04-09","conditions":"HIV, HIV Infections, Pregnancy","enrollment":77},{"nctId":"NCT02475135","phase":"PHASE1","title":"Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination","status":"COMPLETED","sponsor":"Janssen Sciences Ireland UC","startDate":"2015-06-01","conditions":"Healthy","enrollment":72},{"nctId":"NCT01565850","phase":"PHASE2","title":"D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2012-04","conditions":"Acquired Immunodeficiency Syndrome, HIV Infections","enrollment":153}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Darunavir/Cobicistat (FDC)","genericName":"Darunavir/Cobicistat (FDC)","companyName":"Janssen Scientific Affairs, LLC","companyId":"janssen-scientific-affairs-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Darunavir is a protease inhibitor that blocks HIV protease to prevent viral replication, while cobicistat is a boosting agent that inhibits CYP3A4 to increase darunavir levels. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in combination with other antiretroviral agents.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}