biostudies-literatureNachman SNICHD NIH HHSNIAID NIH HHSNICHDe715-e722https://www.ebi.ac.uk/biostudies/studies/S-EPMC6537590biostudies-literatureUnknown5(12)<h4>Background</h4>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.<h4>Methods</h4>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 separateThe lancet. HIVSafety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: a phase 1/2 open label, non-randomised, multicentre trial.PMC6537590UM1 AI069456UM1 AI068632UM1 AI106716HHSN275201800001IHHSN275200800001IHHSN275201800001CUM1 AI068616Fry CSpector SWorrell CSamson PWatson SFenton TKuryla SFrenkel LMIMPAACT 1066 study teamHomony BNachman SBrowning RSPerdue LHazra RAcosta EGraham BLTeppler HZheng NAlvero CTustin NWiznia AARodgers AJDouglas SToye MfalseSafety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: a phase 1/2 open label, non-randomised, multicentre trial.<h4>Background</h4>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.<h4>Methods</h4>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 separate2018-01-01T00:00:00Z2018 Dec2026-05-07T04:26:53.91Z2019-06-06T23:19:31ZS-EPMC65375903052732910.1016/S2352-3018(18)30257-110.1016/s2352-3018(18)30257-1