{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T10:04:00Z","timestamp":1790503440320,"version":"4.1.0"},"reference-count":44,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2021,2,9]],"date-time":"2021-02-09T00:00:00Z","timestamp":1612828800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie, Inc","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Merck, Sharp & Dohme Corporation"},{"name":"Merck & Co, Inc"},{"name":"Pfizer, Inc."},{"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":["AI068634"],"award-info":[{"award-number":["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 AI069476"],"award-info":[{"award-number":["UM1 AI069476"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,8,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Protease inhibitor-based antiretroviral therapy may be used in resource-limited settings in persons with human immunodeficiency virus and tuberculosis (HIV-TB). Data on safety, pharmacokinetics\/pharmacodynamics (PK\/PD), and HIV-TB outcomes for lopinavir\/ritonavir (LPV\/r) used with rifampin (RIF) or rifabutin (RBT) are limited.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We randomized adults with HIV-TB from July 2013 to February 2016 to arm A, LPV\/r 400 mg\/100 mg twice daily + RBT 150 mg\/day; arm B, LPV\/r 800 mg\/200 mg twice daily + RIF 600 mg\/day; or arm C, LPV\/r 400 mg\/100 mg twice daily + raltegravir (RAL) 400 mg twice daily + RBT 150 mg\/day. All received two nucleoside reverse transcriptase inhibitors and other TB drugs. PK visits occurred on day 12 \u00b1 2. Within-arm HIV-TB outcomes were summarized using proportions and 95% CIs; PK were compared using Wilcoxon tests.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among 71 participants, 52% were women; 72% Black; 46% Hispanic; median age, 37 years; median CD4+ count, 130 cells\/mm3; median HIV-1 RNA, 4.6 log10 copies\/mL; 46% had confirmed TB. LPV concentrations were similar across arms. Pooled LPV AUC12 (157 203 hours \u00d7 ng\/mL) and Ctrough (9876 ng\/mL) were similar to historical controls; RBT AUC24 (7374 hours \u00d7 ng\/mL) and Ctrough (208 ng\/mL) were higher, although 3 participants in arm C had RBT Cmax &amp;lt;250 ng\/mL. Proportions with week 48 HIV-1 RNA &amp;lt;400 copies\/mL were 58%, 67%, and 61%, respectively, in arms A, B, and C.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Double-dose LPV\/r+RIF and LPV\/r+RBT 150mg\/day had acceptable safety, PK and TB outcomes; HIV suppression was suboptimal but unrelated to PK. Faster RBT clearance and low Cmax in 3 participants on RBT+RAL requires further study.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab097","type":"journal-article","created":{"date-parts":[[2021,2,3]],"date-time":"2021-02-03T23:28:12Z","timestamp":1612394892000},"page":"706-715","source":"Crossref","is-referenced-by-count":8,"title":["Safety and Pharmacokinetics of Double-Dose Lopinavir\/Ritonavir + Rifampin Versus Lopinavir\/Ritonavir + Daily Rifabutin for Treatment of Human Immunodeficiency Virus\u2013Tuberculosis Coinfection"],"prefix":"10.1093","volume":"73","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9160-4544","authenticated-orcid":false,"given":"Michelle A","family":"Kendall","sequence":"first","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T.H. 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