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Although the effectiveness of TDF in preventing perinatal HIV infection is well established, information about renal safety during pregnancy is still limited.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial design<\/jats:title>\n                <jats:p>The IMPAACT PROMISE study was an open-label, strategy trial that randomized pregnant women to one of three arms: TDF based antiretroviral therapy (ART), zidovudine (ZDV) based ART, and ZDV alone (standard of care at start of enrollment). The P1084s substudy was a nested, comparative study of renal outcomes in women and their infants.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>PROMISE participants (n\u2009=\u20093543) were assessed for renal dysfunction using calculated creatinine clearance (CrCl) at study entry (&gt;\u200914\u00a0weeks gestation), delivery, and postpartum weeks 6, 26, and 74. Of these women, 479 were enrolled in the P1084s substudy that also assessed maternal calcium and phosphate as well as infant calculated CrCl, calcium, and phosphate at birth.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Among the 1338 women who could be randomized to TDF, less than 1% had a baseline calculated CrCl below 80\u00a0mL\/min. The mean (standard deviation) maternal calculated CrCl at delivery in the TDF-ART arm [147.0\u00a0mL\/min (51.4)] was lower than the ZDV-ART [155.0\u00a0mL\/min (43.3); primary comparison] and the ZDV Alone [158.5\u00a0mL\/min (45.0)] arms; the mean differences (95% confidence interval) were \u2212\u00a08.0\u00a0mL\/min (\u2212\u00a014.5, \u2212\u00a01.5) and \u2212\u00a011.5\u00a0mL\/min (\u2212\u00a018.0, \u2212\u00a04.9), respectively. The TDF-ART arm had lower mean maternal phosphate at delivery compared with the ZDV-ART [\u2212\u00a00.14\u00a0mg\/dL (\u2212\u00a00.28, \u2212\u00a00.01)] and the ZDV Alone [\u2212\u00a00.17\u00a0mg\/dL (\u2212\u00a00.31, \u2212\u00a00.02)] arms, and a greater percentage of maternal hypophosphatemia at delivery (4.23%) compared with the ZDV-ART (1.38%) and the ZDV Alone (1.46%) arms. Maternal calcium was similar between arms. In infants, mean calculated CrCl, calcium, and phosphate at birth were similar between arms (all CIs included 0).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Although mean maternal calculated CrCl at Delivery was lower in the TDF-ART arm, the difference between arms is unlikely to be clinically significant. During pregnancy, the TDF-ART regimen had no observed safety concerns for maternal or infant renal function.<\/jats:p>\n                <jats:p><jats:italic>Trial Registration<\/jats:italic>: NCT01061151 on 10\/02\/2010 for PROMISE (1077BF). NCT01066858 on 10\/02\/2010 for P1084s.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12879-022-07608-8","type":"journal-article","created":{"date-parts":[[2022,7,20]],"date-time":"2022-07-20T10:02:49Z","timestamp":1658311369000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Kristin","family":"Baltrusaitis","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bonus","family":"Makanani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Camlin","family":"Tierney","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary 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Study conduct adhered to international guidelines, and the substudy was approved by an institutional review board or ethics committee at each site and corresponding collaborating institutions in the United States. Ethics committees and institutional review boards that approved this study include\u2014MUJHU\/Kampala, Uganda: The Joint Clinical Research Centre (JCRC) IRB, the National Drug Authority in Uganda and the Johns Hopkins Medical Institutions (JHMI) IRB in the U.S.; Wits RHI Shandukani CRS and Soweto IMPAACT CRS, Johannesburg, South Africa: University of Witwatersrand Human Ethics Research Committee (Medical), Medicines Control Council (South African Health Products Regulatory Authority in February 2018); FAM-CRU CRS, Cape town, South Africa: Health Research Ethics Committee (HREC), Faculty of Health Sciences, Stellenbosch University and Medicines Control Council (South African Health Products Regulatory Authority in February 2018); CAPRISA Umlazi CRS, Durban, South Africa: University of KwaZulu-Natal (UKZN) Biomedical Research Ethics Committee, Medicines Control Council (South African Health Products Regulatory Authority in February 2018);George CRS, Lusaka, Zambia: University of North Carolina (UNC) at Chapel Hill Biomedical IRB and University of Zambia Biomedical Research Ethics Committee (UNZABREC); Harare, Seke North and St. Mary\u2019s sites, Zimbabwe: Medical Research Council of Zimbabwe (MRCZ), Research Council of Zimbabwe (RCZ), Medicine Control Authority of Zimbabwe (MCAZ), Joint Parirenyatwa group of Hospitals\/University of Zimbabwe College of Health Sciences Research Ethics Committee (JREC); Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune, India: BJ Government College CTU Ethics Committee and Johns Hopkins IRB; Blantyre, Malawi: College of Medicine Research and Ethics Committee (COMREC) in Malawi, Pharmacy, Medicines and Poisons Board and Johns Hopkins Medical Institutions (JHMI) IRB in the U.S.; Lilongwe, Malawi: National Health Sciences Research Committee (NHSRC) in Malawi Pharmacy, Medicines and Poisons Board, and University of North Carolina, Chapel Hill (UNC-CH) Office of Human Research Ethics IRB in the U.S and Kilimanjaro Christian Medical Centre (KCMC), Moshi, Tanzania: Kilimanjaro Christian Medical College Ethics Committee, National HREC and Tanzania Medicines and Medical Devices Authority.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors have no conflicts of interest to disclose.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"634"}}