{"id":"zdv-3tc-lpv-r","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Lipid abnormalities"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Pancreatitis"},{"rate":null,"effect":"Mitochondrial toxicity"}]},"_chembl":{"chemblId":"CHEMBL48518","moleculeType":"Small molecule","molecularWeight":"327.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ZDV (zidovudine) and 3TC (lamivudine) are nucleoside reverse transcriptase inhibitors that block HIV reverse transcriptase, while LPV/r (lopinavir/ritonavir) is a protease inhibitor that prevents HIV protease from cleaving viral polyproteins. Together, they target multiple steps of the HIV replication cycle to reduce viral load and preserve immune function.","oneSentence":"This combination inhibits HIV reverse transcriptase and protease to suppress viral replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:16:27.902Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HIV-1 infection in pediatric and adolescent patients"},{"name":"Prevention of mother-to-child transmission of HIV"}]},"trialDetails":[{"nctId":"NCT02016924","phase":"PHASE2, PHASE3","title":"Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV","status":"ACTIVE_NOT_RECRUITING","sponsor":"Gilead Sciences","startDate":"2014-01-16","conditions":"Acquired Immune Deficiency Syndrome (AIDS), HIV Infections","enrollment":133},{"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":"NCT02369406","phase":"PHASE2, PHASE3","title":"Early Infant HIV Treatment in Botswana","status":"ACTIVE_NOT_RECRUITING","sponsor":"Harvard School of Public Health (HSPH)","startDate":"2015-05-04","conditions":"HIV, Pediatric AIDS","enrollment":67},{"nctId":"NCT00476606","phase":"","title":"A Prospective Cohort of Children With HIV Infection","status":"COMPLETED","sponsor":"The HIV Netherlands Australia Thailand Research Collaboration","startDate":"2003-03","conditions":"HIV Infections","enrollment":500},{"nctId":"NCT02712801","phase":"PHASE4","title":"Antiretroviral Regime for Viral Eradication in Newborns","status":"COMPLETED","sponsor":"National Center for Women and Children's Health, China CDC","startDate":"2016-04","conditions":"HIV/AIDS and Infections","enrollment":600},{"nctId":"NCT00039741","phase":"PHASE2, PHASE3","title":"Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2002-08","conditions":"HIV Infections","enrollment":266},{"nctId":"NCT00084149","phase":"PHASE2","title":"Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2004-02","conditions":"HIV Infections","enrollment":54},{"nctId":"NCT00099632","phase":"PHASE2","title":"Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2006-03","conditions":"HIV Infections","enrollment":484},{"nctId":"NCT00102960","phase":"PHASE3","title":"Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2005-07","conditions":"HIV Infections","enrollment":377},{"nctId":"NCT01511237","phase":"PHASE3","title":"Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers","status":"COMPLETED","sponsor":"Institut de Recherche pour le Developpement","startDate":"2011-12","conditions":"HIV Infections","enrollment":379},{"nctId":"NCT01818258","phase":"PHASE4","title":"IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children","status":"COMPLETED","sponsor":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","startDate":"2015-10-26","conditions":"HIV Positive, Malnourished","enrollment":52},{"nctId":"NCT01352715","phase":"PHASE3","title":"Study of Options for Second-Line Effective Combination Therapy (SELECT)","status":"COMPLETED","sponsor":"Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections","startDate":"2012-03-13","conditions":"HIV-1 Infection","enrollment":515},{"nctId":"NCT03394196","phase":"NA","title":"RESIST-2: 2nd-line ART for HIV-2 Infection","status":"TERMINATED","sponsor":"University of Washington","startDate":"2018-07-04","conditions":"HIV-2 Infection","enrollment":152},{"nctId":"NCT02431975","phase":"PHASE4","title":"Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial","status":"COMPLETED","sponsor":"Columbia University","startDate":"2015-08","conditions":"HIV","enrollment":73},{"nctId":"NCT00887120","phase":"PHASE2","title":"Dose Reduction of Lopinavir in Children","status":"COMPLETED","sponsor":"The HIV Netherlands Australia Thailand Research Collaboration","startDate":"2007-04","conditions":"HIV Infections","enrollment":24},{"nctId":"NCT02150993","phase":"PHASE2, PHASE3","title":"First-Line Treatment for HIV-2","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2016-01-26","conditions":"HIV-2 Infection","enrollment":210},{"nctId":"NCT00993031","phase":"PHASE3","title":"Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2009-12-15","conditions":"Malaria, HIV Infections","enrollment":389},{"nctId":"NCT00978068","phase":"PHASE3","title":"HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2009-09","conditions":"Malaria, HIV Infections","enrollment":176},{"nctId":"NCT00427297","phase":"PHASE3","title":"Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya","status":"TERMINATED","sponsor":"University of Washington","startDate":"2007-09","conditions":"HIV Infections","enrollment":34},{"nctId":"NCT02231281","phase":"PHASE3","title":"Early cART and cART in Combination With Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in The Treatment of Acute HIV-1 Infected Adults","status":"UNKNOWN","sponsor":"Yongtao Sun, MD, PhD","startDate":"2014-08","conditions":"Acute HIV Infection","enrollment":65},{"nctId":"NCT00307151","phase":"PHASE2","title":"Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV","status":"COMPLETED","sponsor":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","startDate":"2005-12","conditions":"HIV Infections","enrollment":452},{"nctId":"NCT00719602","phase":"EARLY_PHASE1","title":"Differences in Malaria Infection Levels in HIV-infected Infants and Children Receiving PI- and NNRTI-based HAART","status":"COMPLETED","sponsor":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","startDate":"2009-08","conditions":"HIV Infections, Malaria","enrollment":105},{"nctId":"NCT00708162","phase":"PHASE3","title":"Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2008-07","conditions":"HIV Infection","enrollment":724},{"nctId":"NCT00234091","phase":"PHASE3","title":"When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2006-04","conditions":"HIV Infections","enrollment":300},{"nctId":"NCT00865475","phase":"PHASE4","title":"Prevention of Lipoatrophy in Patients Treated With Lopinavir/Ritonavir in Monotherapy Versus ZDV + 3TC + ABC","status":"COMPLETED","sponsor":"Fundacion SEIMC-GESIDA","startDate":"2008-12","conditions":"HIV Infection, HIV Infections","enrollment":38},{"nctId":"NCT00342355","phase":"PHASE4","title":"Antiretroviral Therapy for Advanced HIV Disease in South Africa","status":"COMPLETED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2004-01","conditions":"HIV","enrollment":1771},{"nctId":"NCT00936195","phase":"PHASE3","title":"Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations for HIV-1 PMTCT in Pregnant and Breastfeeding Women : a Phase 3 Trial","status":"WITHDRAWN","sponsor":"French National Agency for Research on AIDS and Viral Hepatitis","startDate":"2010-01","conditions":"HIV Infection, Pregnancy, Breastfeeding","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"FOETAL EXPOSURE DURING PREGNANCY"},{"count":1,"reaction":"MATERNAL DRUGS AFFECTING FOETUS"},{"count":1,"reaction":"NEONATAL ASPHYXIA"}],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Zidovudine","Retrovir","Lamivudine","Epivir","Lopinavir/ritonavir"],"phase":"marketed","status":"active","brandName":"ZDV+3TC+LPV/r","genericName":"ZDV+3TC+LPV/r","companyName":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","companyId":"international-maternal-pediatric-adolescent-aids-clinical-trials-group","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination inhibits HIV reverse transcriptase and protease to suppress viral replication. Used for HIV-1 infection in pediatric and adolescent patients, Prevention of mother-to-child transmission of HIV.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}