{"id":"https://openalex.org/W4301195367","doi":null,"title":"FDA clarifies rules, allows combining antiretrovirals in clinical trials. Food and Drug Administration.","display_name":"FDA clarifies rules, allows combining antiretrovirals in clinical trials. Food and Drug Administration.","publication_year":1999,"publication_date":"1999-11-19","ids":{"openalex":"https://openalex.org/W4301195367","pmid":"https://pubmed.ncbi.nlm.nih.gov/11367127"},"language":"en","primary_location":{"id":"pmid:11367127","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/11367127","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"AIDS treatment news","raw_type":"Newspaper Article"},"volume":null,"type":"other","is_traditional":false,"indexed_in":["pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":"No 331","first_page":"5","last_page":"6"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10526","display_name":"HIV/AIDS drug development and treatment","score":0.9911999702453613,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10526","display_name":"HIV/AIDS drug development and treatment","score":0.9911999702453613,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10082","display_name":"HIV/AIDS Research and Interventions","score":0.002899999963119626,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.0015999999595806003,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/fda-guidance","display_name":"FDA guidance","score":0.6100000143051147},{"id":"https://openalex.org/keywords/antiretroviral-drugs","display_name":"antiretroviral drugs","score":0.8410000205039978},{"id":"https://openalex.org/keywords/highly-active-antiretroviral-therapy","display_name":"highly active antiretroviral therapy","score":0.8370000123977661},{"id":"https://openalex.org/keywords/clinical-trial-design","display_name":"clinical trial design","score":0.6320000290870667},{"id":"https://openalex.org/keywords/drug-regulation","display_name":"drug regulation","score":0.4790000021457672},{"id":"https://openalex.org/keywords/hiv-drug-development","display_name":"HIV drug development","score":0.5220000147819519},{"id":"https://openalex.org/keywords/regulatory-policy","display_name":"regulatory policy","score":0.4169999957084656}],"concepts":[{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.8232663869857788},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.7752273082733154},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.7437702417373657},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7128797173500061},{"id":"https://openalex.org/C502991105","wikidata":"https://www.wikidata.org/wiki/Q5133849","display_name":"Clinical research","level":2,"score":0.602807343006134},{"id":"https://openalex.org/C3013748606","wikidata":"https://www.wikidata.org/wiki/Q15787","display_name":"Human immunodeficiency virus (HIV)","level":2,"score":0.5409321784973145},{"id":"https://openalex.org/C2776876202","wikidata":"https://www.wikidata.org/wiki/Q1368197","display_name":"New drug application","level":3,"score":0.520786464214325},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.4966452717781067},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.49222031235694885},{"id":"https://openalex.org/C2777267654","wikidata":"https://www.wikidata.org/wiki/Q3519023","display_name":"Test (biology)","level":2,"score":0.48167288303375244},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.46487975120544434},{"id":"https://openalex.org/C2992293740","wikidata":"https://www.wikidata.org/wiki/Q4781752","display_name":"Drug approval","level":3,"score":0.4409772455692291},{"id":"https://openalex.org/C2777494893","wikidata":"https://www.wikidata.org/wiki/Q4781752","display_name":"Approved drug","level":3,"score":0.43763527274131775},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.3187851905822754},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.16024565696716309},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.08821991086006165},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0},{"id":"https://openalex.org/C151730666","wikidata":"https://www.wikidata.org/wiki/Q7205","display_name":"Paleontology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D004345","descriptor_name":"Drug Industry","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004352","descriptor_name":"Drug Resistance, Microbial","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004359","descriptor_name":"Drug Therapy, Combination","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015658","descriptor_name":"HIV Infections","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D019380","descriptor_name":"Anti-HIV Agents","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":true}],"locations_count":1,"locations":[{"id":"pmid:11367127","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/11367127","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"AIDS treatment news","raw_type":"Newspaper Article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9537000060081482,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2087681115","https://openalex.org/W2410092377","https://openalex.org/W4308810211","https://openalex.org/W2114981910","https://openalex.org/W2417042063","https://openalex.org/W2022563768","https://openalex.org/W7100564087","https://openalex.org/W2055730467","https://openalex.org/W2400796810","https://openalex.org/W1997304902"],"abstract_inverted_index":{"In":[0,68],"November":[1],"the":[2,20,46,69,76,100,106,116],"FDA":[3,27,77,107],"wrote":[4],"to":[5,11,40,44,50,61,89],"all":[6,31],"pharmaceutical":[7],"companies":[8,72],"urging":[9],"them":[10],"run":[12],"clinical":[13,32],"trials":[14,33],"for":[15,96],"treatment-experienced":[16],"patients,":[17,85],"and":[18,43,78,91],"clarified":[19],"rules":[21],"on":[22,55],"combining":[23],"antiretroviral":[24],"drugs.":[25,98],"The":[26],"usually":[28],"prefers":[29],"that":[30,105],"only":[34],"test":[35,47],"one":[36,65],"new":[37],"drug,":[38],"due":[39],"safety":[41],"reasons":[42],"make":[45],"results":[48],"easier":[49],"interpret.":[51],"However,":[52,99],"HIV":[53],"patients":[54],"failing":[56],"multi-drug":[57],"regimens,":[58],"may":[59],"need":[60],"take":[62],"more":[63,109],"than":[64],"experimental":[66],"drug.":[67],"past,":[70],"drug":[71],"could":[73],"hide":[74],"behind":[75],"resisted":[79],"testing":[80],"their":[81],"drugs":[82],"with":[83],"advanced":[84],"who":[86],"are":[87,118],"harder":[88],"treat,":[90],"represent":[92],"a":[93],"smaller":[94],"market":[95],"approved":[97],"letter":[101,117],"makes":[102],"it":[103],"clear":[104],"expects":[108],"studies":[110],"in":[111],"these":[112],"patients.":[113],"Portions":[114],"of":[115],"included.":[119]},"counts_by_year":[],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2022-10-05T00:00:00"}