{"id":"comparator-efavirenz","safety":{"commonSideEffects":[{"rate":"25-30","effect":"Dizziness"},{"rate":"15-20","effect":"Rash"},{"rate":"10-15","effect":"Nausea"},{"rate":"10-15","effect":"Headache"},{"rate":"15-25","effect":"CNS effects (impaired concentration, abnormal dreams)"},{"rate":"5-10","effect":"Elevated liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL223228","moleculeType":"Small molecule","molecularWeight":"315.68"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Efavirenz binds directly to HIV reverse transcriptase and inhibits its enzymatic activity, preventing the conversion of viral RNA into DNA. This blocks an essential step in HIV replication and integration into the host genome. It is commonly used as part of combination antiretroviral therapy (cART) for HIV-1 infection.","oneSentence":"Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:07:01.741Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection (as part of combination antiretroviral therapy)"}]},"trialDetails":[{"nctId":"NCT02245022","phase":"PHASE2, PHASE3","title":"Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study","status":"COMPLETED","sponsor":"University of Liverpool","startDate":"2017-03-14","conditions":"HIV, Pregnancy","enrollment":60},{"nctId":"NCT05044962","phase":"NA","title":"Kuwa Free! - Live Free!","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2021-11-26","conditions":"HIV Infections, Contraception, Drug-drug Interaction","enrollment":700},{"nctId":"NCT02403674","phase":"PHASE3","title":"Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-06-05","conditions":"Human Immunodeficiency Virus (HIV)","enrollment":734},{"nctId":"NCT04463784","phase":"NA","title":"Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection","status":"UNKNOWN","sponsor":"Peking Union Medical College Hospital","startDate":"2018-04-01","conditions":"HIV/AIDS, Mental Impairment","enrollment":500},{"nctId":"NCT03251690","phase":"NA","title":"Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression","status":"COMPLETED","sponsor":"Mahidol University","startDate":"2016-10-27","conditions":"Anti-Retroviral Agents, Efavirenz, HIV-1-infection","enrollment":246},{"nctId":"NCT01516970","phase":"PHASE3","title":"Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)","status":"COMPLETED","sponsor":"Janssen-Cilag G.m.b.H","startDate":"2011-11-25","conditions":"Human Immunodeficiency Virus (HIV)","enrollment":312},{"nctId":"NCT00369941","phase":"PHASE3","title":"A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-08","conditions":"HIV Infections","enrollment":566},{"nctId":"NCT00100048","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2005-01","conditions":"HIV Infections, Acquired Immunodeficiency Syndrome","enrollment":206},{"nctId":"NCT01343225","phase":"PHASE4","title":"Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection","status":"UNKNOWN","sponsor":"East Carolina University","startDate":"2011-05","conditions":"HIV","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2010,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Sustiva®"],"phase":"phase_3","status":"active","brandName":"Comparator: efavirenz","genericName":"Comparator: efavirenz","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication. Used for HIV-1 infection (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}}