{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T23:58:34Z","timestamp":1790812714445,"version":"4.1.0"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T00:00:00Z","timestamp":1752537600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI068634"],"award-info":[{"award-number":["UM1 AI068634"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI068636"],"award-info":[{"award-number":["UM1 AI068636"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI106701"],"award-info":[{"award-number":["UM1 AI106701"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI069412"],"award-info":[{"award-number":["UM1 AI069412"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["VRC07-523LS"],"award-info":[{"award-number":["VRC07-523LS"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016820","name":"Vaccine Research Center","doi-asserted-by":"publisher","award":["VRC07-523LS"],"award-info":[{"award-number":["VRC07-523LS"]}],"id":[{"id":"10.13039\/100016820","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016820","name":"Vaccine Research Center","doi-asserted-by":"publisher","award":["VRC07-523LS"],"award-info":[{"award-number":["VRC07-523LS"]}],"id":[{"id":"10.13039\/100016820","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016820","name":"Vaccine Research Center","doi-asserted-by":"publisher","award":["VRC07-523LS"],"award-info":[{"award-number":["VRC07-523LS"]}],"id":[{"id":"10.13039\/100016820","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,2,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Long-acting regimens are needed to expand antiretroviral therapy (ART) options for people with human immunodeficiency virus type 1 (HIV-1). Combining broadly neutralizing antibodies (bNAbs) with long-acting small-molecule antiretrovirals may offer an alternative to daily oral therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a phase 2, open-label, single-arm trial at AIDS Clinical Trials Group (ACTG) sites across the United States. Eligible adults had HIV-1 virologically suppressed on ART for \u22652 years, CD4 count \u2265350\u2005cells\/\u03bcL, and susceptibility to VRC07-523LS (half-maximal inhibitory concentration \u22640.25\u2005\u00b5g\/mL; inhibition &amp;gt;98%). Participants completed an oral cabotegravir (CAB) lead-in (Step 1), then received intravenous VRC07-523LS (40\u2005mg\/kg every 8 weeks) plus intramuscular CAB-LA (every 4 weeks) for 48 weeks (Step 2), followed by a return to standard ART (Step 3). Primary outcomes were treatment-related grade \u22653 adverse events (AEs), treatment discontinuation, and confirmed HIV-1 RNA \u2265200\u2005copies\/mL by week 44. Virologic efficacy was assessed using Kaplan\u2013Meier estimates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Seventy-four participants were enrolled (median age, 54 years; 26% female; 51% non-Hispanic White). Twelve (17%) experienced a primary safety event: 11 (15%) had grade \u22653 AEs, primarily transient infusion reactions, and 1 discontinued due to a grade 1 infusion event. The cumulative probability of virologic failure by week 44 was 7% (95% confidence interval, 3%\u201316%). One participant developed the R263K integrase resistance mutation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The VRC07-523LS plus CAB-LA regimen maintained viral suppression in 93% of participants, with only transient infusion reactions observed; however, instances of virologic breakthrough suggest that future studies should focus on optimizing efficacy outcomes. These results support continued investigation of bNAb-based long-acting ART combinations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaf375","type":"journal-article","created":{"date-parts":[[2025,7,14]],"date-time":"2025-07-14T14:08:01Z","timestamp":1752502081000},"page":"100-108","source":"Crossref","is-referenced-by-count":5,"title":["Phase 2 Trial of Long-Acting Cabotegravir and VRC07-523LS for Viral Suppression in Adults With HIV-1: ACTG A5357"],"prefix":"10.1093","volume":"82","author":[{"given":"Babafemi O","family":"Taiwo","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Northwestern University , Chicago, Illinois ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Zheng","sequence":"additional","affiliation":[{"name":"ACTG Statistical and Data Analysis Center (SDAC), Harvard T. H. Chan School of Public Health , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"ACTG Statistical and Data Analysis Center (SDAC), Harvard T. H. Chan School of Public Health , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leah","family":"Burke","sequence":"additional","affiliation":[{"name":"Department of Medicine, Yale New Haven Health , New Haven, Connecticut ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline D","family":"Reeves","sequence":"additional","affiliation":[{"name":"Labcorp\u2013Monogram Biosciences , San Francisco, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly K","family":"Scarsi","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of Nebraska Medical Center , Omaha, Nebraska ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucio","family":"Gama","sequence":"additional","affiliation":[{"name":"Vaccine Research Center, National Institutes of Health , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christos J","family":"Petropoulos","sequence":"additional","affiliation":[{"name":"Labcorp\u2013Monogram Biosciences , San Francisco, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo F","family":"Belaunzaran-Zamudio","sequence":"additional","affiliation":[{"name":"Contractor for Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Wannamaker","sequence":"additional","affiliation":[{"name":"ViiV Healthcare , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald","family":"D\u2019Amico","sequence":"additional","affiliation":[{"name":"ViiV Healthcare , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parita","family":"Rathod","sequence":"additional","affiliation":[{"name":"DLH Corporation , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharine J","family":"Bar","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of Pennsylvania , Philadelphia, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5345-7942","authenticated-orcid":false,"given":"Pablo","family":"Tebas","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of Pennsylvania , Philadelphia, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the A5357 Study Team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherrie","family":"Wolfe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chad","family":"Achenbach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Short","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su Kyung","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edgar Turner","family":"Overton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Messer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carl","family":"Fichtenbaum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Trentman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Solso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Constance","family":"Benson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena","family":"Sobieszczyk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anyelina","family":"Cantos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Duke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eli","family":"Burnham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles W","family":"Flexner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca L","family":"Becker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raghd","family":"Alyatim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Spitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanessa","family":"Sutton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joslyn","family":"Axinn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Hendler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azquena Munoz","family":"Lopez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonal","family":"Munsiff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Hulse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Wohl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Hoffman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Fry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessenia","family":"Fuentes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Koletar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Harber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amesika","family":"Nyaku","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"ChristieLyn","family":"Costanza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge L Santana","family":"Bagur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigrid","family":"Perez-Frontera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaun","family":"Barcavage","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Stroberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,7,15]]},"reference":[{"key":"2026071700014437000_ciaf375-B1","doi-asserted-by":"crossref","first-page":"106220","DOI":"10.1016\/j.ijantimicag.2020.106220","article-title":"Long-acting drugs and formulations for the treatment and prevention of HIV infection","volume":"57","author":"Flexner","year":"2021","journal-title":"Int J Antimicrob Agents"},{"key":"2026071700014437000_ciaf375-B2","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1038\/s41577-023-00858-w","article-title":"Antiviral neutralizing antibodies: from in vitro to in vivo activity","volume":"23","author":"Burton","year":"2023","journal-title":"Nat Rev Immunol"},{"key":"2026071700014437000_ciaf375-B3","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1097\/COH.0000000000000801","article-title":"Broadly neutralizing antibodies and long-acting antiretroviral drugs as treatments for HIV","volume":"18","author":"Kuritzkes","year":"2023","journal-title":"Curr Opin HIV AIDS"},{"key":"2026071700014437000_ciaf375-B4","doi-asserted-by":"crossref","first-page":"e146","DOI":"10.1016\/S2352-3018(23)00293-X","article-title":"Safety of teropavimab and zinlirvimab with lenacapavir once every 6 months for HIV treatment: a phase 1b, randomised, proof-of-concept study","volume":"11","author":"Eron","year":"2024","journal-title":"Lancet HIV"},{"key":"2026071700014437000_ciaf375-B5","doi-asserted-by":"crossref","first-page":"e868","DOI":"10.1016\/S2352-3018(22)00249-1","article-title":"Two-drug regimens for HIV treatment","volume":"9","author":"Gibas","year":"2022","journal-title":"Lancet HIV"},{"key":"2026071700014437000_ciaf375-B6","doi-asserted-by":"crossref","first-page":"e667","DOI":"10.1016\/S2352-3018(19)30181-X","article-title":"Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial","volume":"6","author":"Gaudinski","year":"2019","journal-title":"Lancet HIV"},{"key":"2026071700014437000_ciaf375-B7","doi-asserted-by":"crossref","first-page":"12669","DOI":"10.1128\/JVI.02213-14","article-title":"Enhanced potency of a broadly neutralizing HIV-1 antibody in vitro improves protection against lentiviral infection in vivo","volume":"88","author":"Rudicell","year":"2014","journal-title":"J Virol"},{"key":"2026071700014437000_ciaf375-B8","doi-asserted-by":"crossref","first-page":"835","DOI":"10.1007\/s40262-021-01005-1","article-title":"Pharmacokinetics and drug\u2013drug interactions of long-acting intramuscular cabotegravir and rilpivirine","volume":"60","author":"Hodge","year":"2021","journal-title":"Clin Pharmacokinet"},{"key":"2026071700014437000_ciaf375-B9","doi-asserted-by":"crossref","first-page":"1646","DOI":"10.1093\/cid\/ciad020","article-title":"Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with human immunodeficiency virus 1 type 1 infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b, noninferiority study","volume":"76","author":"Overton","year":"2023","journal-title":"Clin Infect Dis"},{"key":"2026071700014437000_ciaf375-B10","doi-asserted-by":"publisher","first-page":"e181496","DOI":"10.1172\/jci.insight.181496","article-title":"Virologic effects of broadly neutralizing antibodies VRC01LS and VRC07-523LS on chronic HIV-1 infection","volume":"10","author":"Happe","year":"2025","journal-title":"JCI Insight"},{"key":"2026071700014437000_ciaf375-B11","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1093\/infdis\/jiae486","article-title":"Evaluation and real-world experience of a neutralization susceptibility screening assay for broadly neutralizing anti-HIV-1 antibodies","volume":"231","author":"Pahus","year":"2024","journal-title":"J Infect Dis"},{"key":"2026071700014437000_ciaf375-B12","author":"Clinical Pharmacology Quality Assurance Program"},{"key":"2026071700014437000_ciaf375-B13","doi-asserted-by":"crossref","first-page":"1112","DOI":"10.1056\/NEJMoa1904398","article-title":"Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression","volume":"382","author":"Swindells","year":"2020","journal-title":"N Engl J Med"},{"key":"2026071700014437000_ciaf375-B14","doi-asserted-by":"crossref","first-page":"1450","DOI":"10.1002\/cpt.3240","article-title":"Population pharmacokinetics of cabotegravir following oral administration and long-acting intramuscular injection in real-world people with HIV","volume":"115","author":"Thoueille","year":"2024","journal-title":"Clin Pharmacol Ther"},{"key":"2026071700014437000_ciaf375-B15","volume-title":"Common Terminology Criteria for Adverse Events (CTCAE) v5.0","author":"US Department of Health and Human Services","year":"2017"},{"key":"2026071700014437000_ciaf375-B16","doi-asserted-by":"crossref","first-page":"1201","DOI":"10.21873\/anticanres.14062","article-title":"Systematic review on infusion reactions to and infusion rate of monoclonal antibodies used in cancer treatment","volume":"40","author":"Rombouts","year":"2020","journal-title":"Anticancer Res"},{"key":"2026071700014437000_ciaf375-B17","doi-asserted-by":"crossref","first-page":"5847","DOI":"10.1172\/JCI138099","article-title":"HIV-1 viremia not suppressible by antiretroviral therapy can originate from large T cell clones producing infectious virus","volume":"130","author":"Halvas","year":"2020","journal-title":"J Clin Invest"},{"key":"2026071700014437000_ciaf375-B18","doi-asserted-by":"crossref","first-page":"2696","DOI":"10.1128\/JVI.06591-11","article-title":"Characterization of the R263K mutation in HIV-1 integrase that confers low-level resistance to the second-generation integrase strand transfer inhibitor dolutegravir","volume":"86","author":"Quashie","year":"2012","journal-title":"J Virol"},{"key":"2026071700014437000_ciaf375-B19","doi-asserted-by":"crossref","first-page":"2781","DOI":"10.1097\/00002030-200012010-00018","article-title":"Effect of influenza vaccination on disease progression among HIV-infected persons","volume":"14","author":"Sullivan","year":"2000","journal-title":"AIDS"},{"key":"2026071700014437000_ciaf375-B20","doi-asserted-by":"crossref","first-page":"2289","DOI":"10.1097\/QAD.0000000000001201","article-title":"Standard vaccines increase HIV-1 transcription during antiretroviral therapy","volume":"30","author":"Yek","year":"2016","journal-title":"AIDS"},{"key":"2026071700014437000_ciaf375-B21","doi-asserted-by":"crossref","first-page":"1120","DOI":"10.1097\/QAD.0000000000003841","article-title":"Effects of COVID-19 mRNA vaccination on HIV viremia and reservoir size","volume":"38","author":"Duncan","year":"2022","journal-title":"AIDS"},{"key":"2026071700014437000_ciaf375-B22","doi-asserted-by":"crossref","first-page":"2365","DOI":"10.1097\/QAD.0000000000003733","article-title":"Viral blips and virologic failures following mpox vaccination with MVA-BN among people with HIV","volume":"37","author":"Raccagni","year":"2023","journal-title":"AIDS"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciaf375\/63772058\/ciaf375.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/82\/1\/100\/63772058\/ciaf375.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/82\/1\/100\/63772058\/ciaf375.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T04:01:49Z","timestamp":1784260909000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/82\/1\/100\/8202986"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,15]]},"references-count":22,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,7,15]]},"published-print":{"date-parts":[[2026,2,9]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciaf375","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,1,15]]},"published":{"date-parts":[[2025,7,15]]}}}