{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T15:03:35Z","timestamp":1793286215976,"version":"4.5.0"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T00:00:00Z","timestamp":1761782400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"International Maternal Pediatric Adolescent AIDS Clinical Trials"},{"DOI":"10.13039\/100017973","name":"IMPAACT","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017973","id-type":"DOI","asserted-by":"publisher"}]},{"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\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012264","name":"NIH","doi-asserted-by":"publisher","award":["UM1AI068632"],"award-info":[{"award-number":["UM1AI068632"]}],"id":[{"id":"10.13039\/501100012264","id-type":"DOI","asserted-by":"publisher"}]},{"name":"IMPAACT LOC","award":["UM1AI068616"],"award-info":[{"award-number":["UM1AI068616"]}]},{"name":"IMPAACT SDMC","award":["UM1AI106716"],"award-info":[{"award-number":["UM1AI106716"]}]},{"name":"IMPAACT LC"},{"name":"The University of Cape Town Clinical PK Laboratory"},{"name":"International Pharmacology Specialty Laboratory"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>There are no published data on clofazimine pharmacokinetics during pregnancy, and safety data are limited. We present data from pregnant and postpartum women receiving clofazimine for treatment of rifampicin-resistant tuberculosis (RR-TB).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>IMPAACT P1026s was an observational study to assess the pharmacokinetics of tuberculosis and\/or antiretroviral drugs during pregnancy. Between 2017 and 2019, pregnant women receiving \u22652 second-line antituberculosis drugs in routine care were enrolled in the second or third trimester and had intensive pharmacokinetic sampling at least once during pregnancy, and 2\u20138 weeks postpartum. Pharmacokinetic parameters were estimated using noncompartmental methods and compared between the antepartum and postpartum periods using geometric mean ratios (GMR) with 90% confidence intervals (CIs) and the Wilcoxon signed rank test for paired data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Eleven pregnant women from South Africa, 7 (64%) with HIV, were receiving clofazimine (100\u2005mg daily) at enrollment, of which 82% received clofazimine for more than 8 weeks prior to pharmacokinetic evaluation. Nine (82%) women continued treatment postpartum. Peak plasma concentrations and area-under-the-concentration\u2013time-curve over 12\u2005hours were comparable to historical clofazimine pharmacokinetic data in nonpregnant women with RR-TB but were approximately 30% higher in the third trimester of pregnancy compared to the postpartum period. Eight women and 8 infants experienced at least one severe adverse event while on study but direct relatedness to clofazimine was considered unlikely.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Overall, antepartum and postpartum clofazimine exposures were comparable to those reported in nonpregnant women with RR-TB. Exposures were lower than expected in the postpartum period, particularly compared with the third trimester of pregnancy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiaf504","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T12:17:09Z","timestamp":1759925829000},"page":"16-26","source":"Crossref","is-referenced-by-count":4,"title":["Pharmacokinetics and Safety of Clofazimine in Women With Rifampicin-resistant Tuberculosis During Pregnancy and the Postpartum Period: Results From IMPAACT P1026s"],"prefix":"10.1093","volume":"233","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5349-9509","authenticated-orcid":false,"given":"Jennifer A","family":"Hughes","sequence":"first","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flynn","family":"McMorrow","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3832-8699","authenticated-orcid":false,"given":"Kristina M","family":"Brooks","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus , Aurora, Colorado ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauricio","family":"Pinilla","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5327-1734","authenticated-orcid":false,"given":"Lee","family":"Fairlie","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6242-9863","authenticated-orcid":false,"given":"James S","family":"Ngocho","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Applied Biostatistics, KCMC University , Moshi ,","place":["Tanzania"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Stek","sequence":"additional","affiliation":[{"name":"Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Southern California School of Medicine , Los Angeles, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8569-2293","authenticated-orcid":false,"given":"Brookie M","family":"Best","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacy and Department of Pediatrics, University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences and School of Medicine-Rady Children's Hospital San Diego , San Diego, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Mirochnick","sequence":"additional","affiliation":[{"name":"Division of Neonatology, Department of Pediatrics, Boston University Chobanian and Avedisian School of Medicine , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9070-8699","authenticated-orcid":false,"given":"Lubbe","family":"Wiesner","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen","family":"George","sequence":"additional","affiliation":[{"name":"FHI 360, IMPAACT Operations Center , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Knowles","sequence":"additional","affiliation":[{"name":"Frontier Science Foundation, Laboratory Data Division , Amherst, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renee","family":"Browning","sequence":"additional","affiliation":[{"name":"National Institutes of Health, National Institute of Allergy and Infectious Diseases , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tara","family":"DeYampert","sequence":"additional","affiliation":[{"name":"Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) , Bethesda, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anneke C","family":"Hesseling","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1815-5150","authenticated-orcid":false,"given":"Eric","family":"Decloedt","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, Tygerberg Hospital, Stellenbosch University , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T. 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