{"id":"infant-nevirapine","safety":{"commonSideEffects":[{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Stevens-Johnson syndrome"},{"rate":null,"effect":"Gastrointestinal disturbances"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Nevirapine binds directly to HIV reverse transcriptase and inhibits its enzymatic activity, preventing the conversion of viral RNA to DNA and thus blocking HIV replication. In infants, particularly those exposed perinatally, nevirapine is used as part of antiretroviral therapy to suppress viral load and prevent mother-to-child transmission of HIV.","oneSentence":"Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication in infants.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:16:00.300Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of mother-to-child transmission of HIV in infants"},{"name":"HIV-1 infection in infants and children"}]},"trialDetails":[{"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":"NCT02140255","phase":"PHASE1, PHASE2","title":"Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2015-01-23","conditions":"HIV Infection","enrollment":1120},{"nctId":"NCT00167674","phase":"PHASE2","title":"ARVs to Prevent Breastmilk HIV:Viral and Immune Responses","status":"COMPLETED","sponsor":"University of Washington","startDate":"2003-11-03","conditions":"HIV Infections","enrollment":58},{"nctId":"NCT00074412","phase":"PHASE3","title":"Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2007-01","conditions":"HIV Infections","enrollment":2026},{"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":"NCT03088410","phase":"PHASE4","title":"Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana","status":"COMPLETED","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","startDate":"2016-08-22","conditions":"HIV, Insulin Sensitivity, Diabetes Mellitus","enrollment":495},{"nctId":"NCT01061151","phase":"PHASE3","title":"Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2011-03-01","conditions":"HIV Infections","enrollment":3747},{"nctId":"NCT00000872","phase":"PHASE2","title":"Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"HIV Infections","enrollment":55},{"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":"NCT00006279","phase":"PHASE1","title":"The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"HIV Infections","enrollment":75},{"nctId":"NCT00001135","phase":"PHASE3","title":"A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"HIV Infections, Pregnancy","enrollment":2009},{"nctId":"NCT00000942","phase":"PHASE3","title":"A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Babies","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"HIV Infections, Pregnancy","enrollment":1244},{"nctId":"NCT00000869","phase":"PHASE3","title":"A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"HIV Infections, Pregnancy","enrollment":2009},{"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":"NCT03723525","phase":"PHASE4","title":"Package of Care to Improve Retention in ART and Mortality Among Treatment Naive HIV Infected Individuals","status":"COMPLETED","sponsor":"National Centre for AIDs and STD Control, Nepal","startDate":"2018-01-22","conditions":"HIV","enrollment":1073},{"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":"NCT04278612","phase":"NA","title":"Evaluation of the Effectiveness of a Quality Improvement Intervention","status":"COMPLETED","sponsor":"University of KwaZulu","startDate":"2016-01-18","conditions":"Maternal and Child Health","enrollment":1438},{"nctId":"NCT01229761","phase":"PHASE2","title":"Study to Improve Survival Among HIV-Exposed Infants in Botswana","status":"COMPLETED","sponsor":"Harvard School of Public Health (HSPH)","startDate":"2011-05","conditions":"HIV Infections, Neutropenia, Anemia","enrollment":3724},{"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":"NCT02417675","phase":"NA","title":"Postpartum Adherence Clubs to Enhance Support: the PACER Study","status":"COMPLETED","sponsor":"Columbia University","startDate":"2015-02","conditions":"HIV","enrollment":258},{"nctId":"NCT02269462","phase":"","title":"A Study to Evaluate the Effects of Genetic Factors on the Pharmacokinetics of Antiretroviral Drugs During Pregnancy and Lactation","status":"COMPLETED","sponsor":"Adeniyi Olagunju","startDate":"2012-12","conditions":"HIV, Pregnancy, Breastfeeding","enrollment":460},{"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":"NCT00409591","phase":"PHASE3","title":"Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand","status":"TERMINATED","sponsor":"Institut de Recherche pour le Developpement","startDate":"2008-07","conditions":"HIV Infections, Pregnancy","enrollment":435},{"nctId":"NCT02166502","phase":"","title":"Nevirapine Dosing in Neonates for Prophylaxis of Mother-to-Child-Transmission (MTCT) of HIV Infection","status":"COMPLETED","sponsor":"The Hospital for Sick Children","startDate":"2012-02","conditions":"Human Immunodeficiency Virus, HIV, Vertical Infection Transmission","enrollment":27},{"nctId":"NCT02181933","phase":"PHASE3","title":"Efficacy of Nevirapine Compared to ZDV + 3TC Administered in Labor and Again at Postdelivery in HIV Positive Women","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"1999-04","conditions":"HIV Infections","enrollment":2648},{"nctId":"NCT00115648","phase":"PHASE3","title":"Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission","status":"COMPLETED","sponsor":"Johns Hopkins Bloomberg School of Public Health","startDate":"2004-04","conditions":"HIV Infections","enrollment":3300},{"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":"NCT00197587","phase":"NA","title":"Prevention of Milk-Borne Transmission of HIV-1C in Botswana","status":"COMPLETED","sponsor":"Harvard School of Public Health (HSPH)","startDate":"2002-08","conditions":"HIV Infection, Infant Risk for HIV Infection by MTCT","enrollment":1200},{"nctId":"NCT01157442","phase":"NA","title":"Study of Cell Phone SMS Messages for Prevention of Maternal to Child Transmission of HIV","status":"UNKNOWN","sponsor":"University of Manitoba","startDate":"2010-07","conditions":"HIV Infections","enrollment":856},{"nctId":"NCT00164736","phase":"PHASE3","title":"Breastfeeding, Antiretroviral, and Nutrition Study","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2004-03","conditions":"HIV Infections","enrollment":2369},{"nctId":"NCT00074399","phase":"PHASE3","title":"Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2001-02","conditions":"HIV Infections","enrollment":775},{"nctId":"NCT00061321","phase":"PHASE3","title":"Daily Nevirapine to Prevent Mother to Infant Transmission of HIV","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2002-08","conditions":"HIV Infections","enrollment":770},{"nctId":"NCT00398684","phase":"PHASE3","title":"Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand","status":"COMPLETED","sponsor":"Institut de Recherche pour le Developpement","startDate":"2001-01","conditions":"HIV Infections, Pregnancy","enrollment":1792},{"nctId":"NCT00639938","phase":"PHASE3","title":"Nevirapine Study for the Prevention of Maternal-Infant HIV Transmission in Uganda","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2004-07","conditions":"HIV Infections","enrollment":722}],"_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":["Viramune (Nevirapine) suspension 50mg/5ml"],"phase":"phase_3","status":"active","brandName":"Infant nevirapine","genericName":"Infant nevirapine","companyName":"Centers for Disease Control and Prevention","companyId":"centers-for-disease-control-and-prevention","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication in infants. Used for Prevention of mother-to-child transmission of HIV in infants, HIV-1 infection in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}