{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T11:54:29Z","timestamp":1787313269789,"version":"build-2736575974"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2023,10,26]],"date-time":"2023-10-26T00:00:00Z","timestamp":1698278400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000780","name":"European Union","doi-asserted-by":"publisher","award":["RIA2017MC-2013)"],"award-info":[{"award-number":["RIA2017MC-2013)"]}],"id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Mozambique"},{"name":"EMPIRICAL"},{"name":"PediCAP"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We evaluated dolutegravir pharmacokinetics in infants with human immunodeficiency virus (HIV) receiving dolutegravir twice daily (BID) with rifampicin-based tuberculosis (TB) treatment compared with once daily (OD) without rifampicin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Infants with HIV aged 1\u201312 months, weighing \u22653\u2005kg, and receiving dolutegravir BID with rifampicin or OD without rifampicin were eligible. Six blood samples were taken over 12 (BID) or 24 hours (OD). Dolutegravir pharmacokinetic parameters, HIV viral load (VL) data, and adverse events (AEs) were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty-seven of 30 enrolled infants had evaluable pharmacokinetic curves. The median (interquartile range) age was 7.1 months (6.1\u20139.9), weight was 6.3 kg (5.6\u20137.2), 21 (78%) received rifampicin, and 11 (41%) were female. Geometric mean ratios comparing dolutegravir BID with rifampicin versus OD without rifampicin were area under curve (AUC)0\u201324h 0.91 (95% confidence interval, .59\u20131.42), Ctrough 0.95 (0.57\u20131.59), Cmax 0.87 (0.57\u20131.33). One infant (5%) receiving rifampicin versus none without rifampicin had dolutegravir Ctrough &amp;lt;0.32\u2005mg\/L, and none had Ctrough &amp;lt;0.064\u2005mg\/L. The dolutegravir metabolic ratio (dolutegravir-glucuronide AUC\/dolutegravir AUC) was 2.3-fold higher in combination with rifampicin versus without rifampicin. Five of 82 reported AEs were possibly related to rifampicin or dolutegravir and resolved without treatment discontinuation. Upon TB treatment completion, HIV viral load was &amp;lt;1000\u2005copies\/mL in 76% and 100% of infants and undetectable in 35% and 20% of infants with and without rifampicin, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Dolutegravir BID in infants receiving rifampicin resulted in adequate dolutegravir exposure, supporting this treatment approach for infants with HIV\u2013TB coinfection.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciad656","type":"journal-article","created":{"date-parts":[[2023,10,25]],"date-time":"2023-10-25T08:12:08Z","timestamp":1698221528000},"page":"702-710","source":"Crossref","is-referenced-by-count":12,"title":["Twice-Daily Dosing of Dolutegravir in Infants on Rifampicin Treatment: A Pharmacokinetic Substudy of the EMPIRICAL Trial"],"prefix":"10.1093","volume":"78","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5738-5528","authenticated-orcid":false,"given":"Tom G","family":"Jacobs","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Radboudumc Institute for Medical Innovation, Radboud University Medical Center , Nijmegen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivian","family":"Mumbiro","sequence":"additional","affiliation":[{"name":"University of Zimbabwe Clinical Research Centre , Harare , Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uneisse","family":"Cassia","sequence":"additional","affiliation":[{"name":"Universidade Eduardo Mondlane Faculdade de Medicina , Maputo , Mozambique"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Zimba","sequence":"additional","affiliation":[{"name":"University Teaching Hospitals-Children\u2019s Hospital , Lusaka , 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