{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Nachman S"],"funding":["NICHD NIH HHS","NIAID NIH HHS","NICHD"],"pagination":["e715-e722"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6537590"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["5(12)"],"pubmed_abstract":["Background
Raltegravir is an integrase inhibitor approved for use in adults and children with HIV-1 infection, but there are no data on the long-term use of this medication in children. We aimed to assess the long-term safety, tolerability, pharmacokinetics, and efficacy of multiple raltegravir formulations in children aged 4 weeks to 18 years with HIV-1 infection.Methods
In this phase 1/2 open-label multicentre trial (IMPAACT P1066), done in 43 IMPAACT network sites in the USA, South Africa, Brazil, Botswana, and Argentina, eligible participants were children aged 4 weeks to 18 years with HIV-1 infection who had previously received antiretroviral therapy (ART), had HIV-1 RNA higher than 1000 copies per mL, and no exposure to integrase inhibitors. Participants were separate"],"journal":["The lancet. HIV"],"pubmed_title":["Safety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: a phase 1/2 open label, non-randomised, multicentre trial."],"pmcid":["PMC6537590"],"funding_grant_id":["UM1 AI069456","UM1 AI068632","UM1 AI106716","HHSN275201800001I","HHSN275200800001I","HHSN275201800001C","UM1 AI068616"],"pubmed_authors":["Fry C","Spector S","Worrell C","Samson P","Watson S","Fenton T","Kuryla S","Frenkel LM","IMPAACT 1066 study team","Homony B","Nachman S","Browning RS","Perdue L","Hazra R","Acosta E","Graham BL","Teppler H","Zheng N","Alvero C","Tustin N","Wiznia AA","Rodgers AJ","Douglas S","Toye M"],"additional_accession":[]},"is_claimable":false,"name":"Safety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: a phase 1/2 open label, non-randomised, multicentre trial.","description":"Background
Raltegravir is an integrase inhibitor approved for use in adults and children with HIV-1 infection, but there are no data on the long-term use of this medication in children. We aimed to assess the long-term safety, tolerability, pharmacokinetics, and efficacy of multiple raltegravir formulations in children aged 4 weeks to 18 years with HIV-1 infection.Methods
In this phase 1/2 open-label multicentre trial (IMPAACT P1066), done in 43 IMPAACT network sites in the USA, South Africa, Brazil, Botswana, and Argentina, eligible participants were children aged 4 weeks to 18 years with HIV-1 infection who had previously received antiretroviral therapy (ART), had HIV-1 RNA higher than 1000 copies per mL, and no exposure to integrase inhibitors. Participants were separate","dates":{"release":"2018-01-01T00:00:00Z","publication":"2018 Dec","modification":"2026-05-07T04:26:53.91Z","creation":"2019-06-06T23:19:31Z"},"accession":"S-EPMC6537590","cross_references":{"pubmed":["30527329"],"doi":["10.1016/S2352-3018(18)30257-1","10.1016/s2352-3018(18)30257-1"]}}