{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Baltrusaitis K"],"funding":["NIAID NIH HHS"],"pagination":["634"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9297643"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["22(1)"],"pubmed_abstract":["<h4>Background</h4>Tenofovir disoproxil fumarate (TDF) in combination with other antiretroviral (ARV) drugs has been in clinical use for HIV treatment since its approval in 2001. Although the effectiveness of TDF in preventing perinatal HIV infection is well established, information about renal safety during pregnancy is still limited.<h4>Trial design</h4>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.<h4>Methods</h4>PROMISE participants (n = 3543) were assessed for renal dysfunction using calculated creati"],"journal":["BMC infectious diseases"],"pubmed_title":["Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial."],"pmcid":["PMC9297643"],"funding_grant_id":["UM1 AI069423","UM1 AI069436","UM1 AI069469","UM1 AI068616","UM1 AI069518","U01 AI068632","UM1 AI069463","U01 AI069436"],"pubmed_authors":["Manzella A","Siberry G","Purdue L","Chetty V","Kunje S","Mirochnick M","Grab J","Fenton T","Vhembo T","Weinberg A","Maulidi M","Patil S","Nyati M","Marote E","Chipato T","Butler K","Jennings A","Abrahams N","Makina E","Asiyo C","Mlay P","Mufukari N","Shapiro D","Toone V","Dimairo J","Knowles K","Masenya M","Brummel S","Njau B","PROMISE P1084s Study Team","Toye MP","Stranix-Chibanda L","Heckman B","Siyasiya A","Dittmer S","Currier J","Martinson F","Theron G","Valentine M","Lallemant M","Fowler MG","George K","Makanani B","Chareka G","Chi B","Zadzilka A","Angelidou K","Fairlie L","Nyakudya LH","Siberry GK","Skosana NR","Tomu M","Kabat WB","Owor M","Moodley D","McIntyre J","Barlow-Mosha L","Mawlana S","Luzuriaga K","Mpoudi-Ngole M","Nielsen K","Mutambanengwe M","Tierney C","Rossouw M","Rossouw L","Watts H","Louw J","Read JS","Desmond AC","Kusakara B","Nevreka N","Basar M","Milala B","Klingman K","Sebikari D","Kamateeka M","Coletti A","Bhosale R","Nematadzira T","Taha TE","Baltrusaitis K","Browning R"],"additional_accession":[]},"is_claimable":false,"name":"Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial.","description":"<h4>Background</h4>Tenofovir disoproxil fumarate (TDF) in combination with other antiretroviral (ARV) drugs has been in clinical use for HIV treatment since its approval in 2001. Although the effectiveness of TDF in preventing perinatal HIV infection is well established, information about renal safety during pregnancy is still limited.<h4>Trial design</h4>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.<h4>Methods</h4>PROMISE participants (n = 3543) were assessed for renal dysfunction using calculated creati","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jul","modification":"2026-05-27T21:34:08.738Z","creation":"2022-08-08T11:02:16.239Z"},"accession":"S-EPMC9297643","cross_references":{"pubmed":["35858874"],"doi":["10.1186/s12879-022-07608-8"]}}