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The protocol evaluates cabotegravir (CAB) and rilpivirine (RPV) given as intramuscular injections every 2 months (CAB LA + RPV LA Q2M) versus continued first-line daily oral ART with 2 NRTIs plus dolutegravir in adults with prior sub-optimal adherence. IMPALA is an open-label multicentre randomized trial in Uganda, Kenya, and South Africa, with 540 participants followed for 24 months, assessing non-inferior viral suppression and safety.",{"@graph":69,"@context":122},[70,84,105],{"@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/efficacy-and-safety-of-long-acting-injectable-cabotegravir-and-rilpivirine-in-improving-hiv-1-control-in-sub-saharan-africa-protocol-for-a-phase-3b-open-label-randomized-controlled-trial-impala/138514/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/efficacy-and-safety-of-long-acting-injectable-cabotegravir-and-rilpivirine-in-improving-hiv-1-control-in-sub-saharan-africa-protocol-for-a-phase-3b-open-label-randomized-controlled-trial-impala/138514.png","ImageObject",300,407,{"name":92,"@type":93},"Mason","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-09-20","2026-08-23",true,{"@type":102,"interactionType":103,"userInteractionCount":29},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is IMPALA investigating and why is it important for sub-Saharan Africa?","Question",{"text":112,"@type":113},"IMPALA tests whether switching from daily oral ART to long-acting injectable cabotegravir and rilpivirine is non-inferior in effectiveness while maintaining safety. The focus is improving HIV-1 control for adults with a history of sub-optimal daily pill adherence.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How are participants assigned to treatment in the randomized phase?",{"text":117,"@type":113},"After consent and eligibility screening, viraemic participants are suppressed on oral ART before randomization. On Day 1, participants are randomized 1:1 to continue daily oral ART or switch to CAB LA + RPV LA Q2M, with or without a 1-month oral lead.",{"name":119,"@type":110,"acceptedAnswer":120},"What is the primary endpoint and when is it measured?",{"text":121,"@type":113},"The primary endpoint is achieving HIV-1 RNA \u003C50 copies/mL at 12 months based on the FDA snapshot approach.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},138514,1787482270,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":29,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":129,"read_time":144},5909887256941,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","STUDY PROTOCOL  \nEfficacy and Safety of Long-acting Injectable Cabotegravirand Rilpivirine in Improving HIV-1 Control in sub-Saharan Africa: Protocol for a Phase 3b Open-Label Randomized Controlled Trial (IMPALA)  \n[version 1; peer review: 1 approved]  \nVictoria Babirye Tumusiime 1, Eugene Ruzagira 1,2, Claire Norcross 1,3, Ingrid Eshun-Wilsonova4, Jonathan Kitonsa 1,3, Ubaldo Mushabe Bahemuka 1, Daniel Grint 2, Geofrey Kimbugwe 1, Ayoub Kakande 1, David S Lawrence5-7, Fridah Mwendia 8, Rodica Van Solingen9, Veerle Van Eygen9,  \nFafa Addo Boateng 10, Fiona Cresswell 1,3,5, IMPALA study team  \n1 HIV interventions, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Central Region, 256, Uganda  \n2 Department of Infectious Diseases Epidemiology, London School of Hygiene and Tropical Medicine Faculty of Epidemiology and Population Health, London, England, UK  \n3Global Health and Infectious, Brighton and Sussex Medical School, Brighton, England, UK  \n4Johnson & Johnson, CapeTown, South Africa  \n5 Department of Clinical Research, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, England, UK  \n6 Botswana Harvard Health Partnership, Gaborone, Botswana  \n7School of Pathology, Faculty of Health Sciences , University of Witwatersrand, Johannesburg, South Africa  \n8Johnson & Johnson, East Africa, Nairobi, Kenya  \n9Jansenn Research and Development, Beerse, Belgium  \n10Johnson & Johnson Middle East FZ LLC, Accra, Ghana  \nv1  \nFirst published: 28 Mar 2025, 10:166  \n[https://doi.org/10.12688/wellcomeopenres.23363.1](https://doi.org/10.12688/wellcomeopenres.23363.1)  \n[Latest published:](Latest published: 28 Mar 2025)[ 28 Mar 2025](Latest published: 28 Mar 2025), 10:166  \n[https://doi.org/10.12688/wellcomeopenres.23363.1](https://doi.org/10.12688/wellcomeopenres.23363.1)  \nAbstract  \nLong-acting (LA) injectable therapy as treatment for HIV-1 infection offers reduced dosing frequency, increased discretion and provides an alternative to two or three-drug daily oral combinations. A parenteral LA formulation of cabotegravir (CAB) and rilpivirine (RPV) given by intramuscular (IM) injection every 2 months (CAB LA + RPV LA Q2M) has shown safety and efficacy in phase 3/3b trials and could increase treatment satisfaction and improve adherence in sub-Saharan Africa.  \nIMPALA (IMProving HIV-1 Control in Africa using Long-Acting Antiretrovirals) is a randomized, controlled, open-label, multicentre,  \nOpen Peer Review  \nApproval Status   \n1  \n1. Eisuke Adachi, The University of Tokyo, IMSUT Hospital, Tokyo, Japan  \nAny reports and responses or comments on the  \narticle can be found at the end of the article.  \ninterventional study in Uganda, Kenya, and South Africa of 540 virologically suppressed adults living with HIV-1 infection with a history of sub-optimal adherence to daily oral ART . IMPALA seeks to demonstrate the non-inferior antiviral effectiveness of switching to CAB LA + RPV LA Q2M, compared to the continuation of first-line daily oral ART containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus dolutegravir (DTG) . After providing informed consent, participants are screened for eligibility. Those who are viraemic (HIV RNA ≥200 copies/mL) at screening will be suppressed (\u003C200 copies/mL for ≥3 months) on oral ART prior to randomization. On Day 1, individuals will be randomized 1:1 to either continue daily oral ART, or switch to CAB LA + RPV LA Q2M,(intervention arm) with or without a 1-month oral lead consisting of once daily oral CAB + RPV. The total follow-up period is 24 months. The primary endpoint is HIV-1 RNA \u003C50 copies/ml at 12 months by FDA snapshot.  \nInitial: TMC278LAHTX3005 Version Amendment 1, 30 September 2022  \nSuperseded by: TMC278LAHTX3005 Version Amendment 2, 3 June 2024  \nThis clinical trial was registered on [Clinical Trials.gov](Clinical Trials.gov) on 19 September 2022 (NCT05546242), available from [https://clinicaltrials.gov/ct2/show/NCT05546242](https:/","cbCaioK8fxPZaTg7","https://ap.wps.com/l/cbCaioK8fxPZaTg7","pdf",2133666,18,"English","# Study overview and rationale\n## Intervention and comparator\n## Eligibility screening and suppression procedure\n# Randomization and trial procedures\n## Treatment arms and oral lead\n## Follow-up schedule and endpoints\n# Trial registration and administrative information","[{\"question\":\"What is IMPALA investigating and why is it important for sub-Saharan Africa?\",\"answer\":\"IMPALA tests whether switching from daily oral ART to long-acting injectable cabotegravir and rilpivirine is non-inferior in effectiveness while maintaining safety. The focus is improving HIV-1 control for adults with a history of sub-optimal daily pill adherence.\"},{\"question\":\"How are participants assigned to treatment in the randomized phase?\",\"answer\":\"After consent and eligibility screening, viraemic participants are suppressed on oral ART before randomization. On Day 1, participants are randomized 1:1 to continue daily oral ART or switch to CAB LA + RPV LA Q2M, with or without a 1-month oral lead.\"},{\"question\":\"What is the primary endpoint and when is it measured?\",\"answer\":\"The primary endpoint is achieving HIV-1 RNA \\u003c50 copies/mL at 12 months based on the FDA snapshot approach.\"}]","Efficacy and Safety of Long-acting Injectable Cabotegravir and Rilpivirine in Improving HIV-1 Control in sub-Saharan Africa - Protocol for a Phase 3b Open-Label Randomized Controlled Trial (IMPALA) | PDF",45]