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The protocol is sponsored by the Division of AIDS, National Institute of Allergy and Infectious Diseases, with pharmaceutical support from ViiV Healthcare and Gilead Sciences, Inc. It includes study design and randomization, oral lead-in rationale, objectives across primary, secondary, tertiary, and exploratory domains, plus sections addressing study population and multiple counseling and monitoring elements.",{"@graph":69,"@context":121},[70,84,104],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/hptn-083-final-version-50-protocol/342978/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":98,"encodingFormat":97,"isAccessibleForFree":99,"interactionStatistic":100},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/hptn-083-final-version-50-protocol/342978.png","ImageObject",300,407,{"name":92,"@type":93},"Genevieve","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-09-22",true,{"@type":101,"interactionType":102,"userInteractionCount":4},"InteractionCounter",{"@type":103},"ViewAction",{"@type":105,"mainEntity":106},"FAQPage",[107,113,117],{"name":108,"@type":109,"acceptedAnswer":110},"What is the primary comparison in HPTN 083?","Question",{"text":111,"@type":112},"Injectable cabotegravir is compared with daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for HIV pre-exposure prophylaxis.","Answer",{"name":114,"@type":109,"acceptedAnswer":115},"What study design does the protocol use?",{"text":116,"@type":112},"The study is described as a Phase 2b/3 double-blind safety and efficacy study with a randomized design.",{"name":118,"@type":109,"acceptedAnswer":119},"Who sponsors and provides pharmaceutical support for the study?",{"text":120,"@type":112},"The protocol is sponsored by the Division of AIDS, National Institute of Allergy and Infectious Diseases, and pharmaceutical support is provided by ViiV Healthcare and Gilead Sciences, Inc.","https://schema.org",{"og:url":83,"og:type":123,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":125,"canonical":83},"index,follow",{"doc_id":127,"site_id":62},342978,1790049227,{"code":4,"msg":5,"data":130},{"doc_id":127,"user_id":131,"nickname":92,"user_avatar":132,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":133,"file_id":134,"file_url":135,"file_type":136,"file_size":137,"view_count":4,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":138,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":128,"read_time":143},1374391974585,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","HPTN 083  \nA Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIVUninfected Cisgender Men and Transgender Women who have Sex with Men  \nDAIDS Document ID: 20725  \nA Study by the HIV Prevention Trials Network  \nSponsored by:  \nDivision of AIDS, National Institute of Allergy and Infectious Diseases  \nPharmaceutical Support Provided by:  \nViiV Healthcare  \nGilead Sciences, Inc  \nIND \\# 122, 744  \nProtocol Chair:  \nRaphael J. Landovitz, M.D., M. Sc.  \nProtocol Co-Chair:  \nBeatriz Grinsztejn, M.D., Ph.D.  \nFinal Version 5.0  \nApril 28, 2022  \nHPTN 083  \nA Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men  \nTABLE OF CONTENTS  \nTABLE OF CONTENTS ..........................................................................................................................................................2  \nPROTOCOL SIGNATURE PAGE..........................................................................................................................................5  \nLIST OF ABBREVIATIONS AND ACRONYMS .................................................................................................................6  \nPROTOCOL TEAM ROSTER .............................................................................................................................................. 11  \nTERMINOLOGY FOR CABOTEGRAVIR AND TDF/FTC FORMULATIONS ...........................................................16  \nSCHEMA.................................................................................................................................................................................. 17  \nOVERVIEW OF STUDY DESIGN AND RANDOMIZATION SCHEME .......................................................................21  \n1.0 INTRODUCTION .....................................................................................................................................................22  \n1.1 BACKGROUND AND RATIONALE ....................................................................................................................................................... 22  \n1.2 OVERVIEW OF ORAL CABOTEGRAVIR (ORAL CAB) AND LONG-ACTING INJECTABLE (CAB LA) ........................................................ 23  \n1.3 DOSE RATIONALE ............................................................................................................................................................................ 25  \n1.4 CLINICAL EXPERIENCE TO DATE: ORAL CAB AND CAB LA............................................................................................................. 34  \n1.5 HEPATIC AND CENTRAL NERVOUS SYSTEM ADVERSE EVENTS.......................................................................................................... 37  \n1.6 BACKGROUND OF TDF/FTC FOR PRE-EXPOSURE PROPHYLAXIS ....................................................................................................... 38  \n1.7 RATIONALE FOR STUDY DESIGN ....................................................................................................................................................... 40  \n1.8 RATIONALE FOR BONE MINERAL DENSITY SUBSET ........................................................................................................................... 41  \n1.9 RECRUITING AND RETAINING MOST AT RISK POPULATIONS ............................................................................................................. 41  \n1.10 HIV AND RISK REDUCTION COUNSELING ......................................................................................................................................... 42  \n1.11 ADHERENCE COUNS","cbCaiut4grATnzz5","https://ap.wps.com/l/cbCaiut4grATnzz5","pdf",2016464,242,"English","# TABLE OF CONTENTS\n## PROTOCOL SIGNATURE PAGE\n## LIST OF ABBREVIATIONS AND ACRONYMS\n## PROTOCOL TEAM ROSTER\n## TERMINOLOGY FOR CABOTEGRAVIR AND TDF/FTC FORMULATIONS\n## SCHEMA\n## OVERVIEW OF STUDY DESIGN AND RANDOMIZATION SCHEME\n## 1.0 INTRODUCTION\n## 2.0 STUDY OBJECTIVES AND DESIGN\n## 3.0 STUDY POPULATION","[{\"question\":\"What is the primary comparison in HPTN 083?\",\"answer\":\"Injectable cabotegravir is compared with daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for HIV pre-exposure prophylaxis.\"},{\"question\":\"What study design does the protocol use?\",\"answer\":\"The study is described as a Phase 2b/3 double-blind safety and efficacy study with a randomized design.\"},{\"question\":\"Who sponsors and provides pharmaceutical support for the study?\",\"answer\":\"The protocol is sponsored by the Division of AIDS, National Institute of Allergy and Infectious Diseases, and pharmaceutical support is provided by ViiV Healthcare and Gilead Sciences, Inc.\"}]","HPTN 083 - Final Version 5.0 - Protocol | PDF",610]