{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["22(1)"],"submitter":["Chiappini E"],"pubmed_abstract":["<h4>Background</h4>Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2-12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.<h4>Methods</h4>An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.<h4>Results</h4>22.2% (50/225) of included children were receivin"],"journal":["BMC infectious diseases"],"pagination":["55"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8760752"],"repository":["biostudies-literature"],"pubmed_title":["Off-label use of combined antiretroviral therapy, analysis of data collected by the Italian Register for HIV-1 infection in paediatrics in a large cohort of children."],"pmcid":["PMC8760752"],"pubmed_authors":["Carloni I","Parigi S","Felici L","Bruzzese E","Bondi E","Nogare ERD","Natale F","Dedoni M","Italian Register for HIV Infection in Children","Abbagnato L","Ruggeri M","Galli L","Taramasso L","de Martino M","Consolini R","Faldella G","Lisi C","Rampon O","Chiriaco P","Genovese O","Gabiano C","Giacomet V","Anzidei G","Anastasio E","Borea R","Pession A","Giaquinto C","Di Pietro GM","Esposito S","Dodi I","Portelli V","Erba P","Giannini AM","Bernardi S","Zangari P","Tovo PA","Baldi F","de Martino A","Antonellini A","Dessi C","Bigi M","Chiappini E","Di Biagio A","Panto MG","Cellini M","Salvini F","Orlandi F","Cenderello G","Tommasi D","Pinzani R","Govoni MR","Olmeo P","Zanaboni D","Rabusin M","Saitta M","Cristiano L","Badolato R","Garazzino S","Mazza A","Tagliabue C","Catania S","Cazzato S","Fabrizio L"],"additional_accession":[]},"is_claimable":false,"name":"Off-label use of combined antiretroviral therapy, analysis of data collected by the Italian Register for HIV-1 infection in paediatrics in a large cohort of children.","description":"<h4>Background</h4>Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2-12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.<h4>Methods</h4>An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.<h4>Results</h4>22.2% (50/225) of included children were receivin","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jan","modification":"2026-05-08T14:05:01.14Z","creation":"2022-02-11T15:26:22.72Z"},"accession":"S-EPMC8760752","cross_references":{"pubmed":["35033018"],"doi":["10.1186/s12879-022-07026-w"]}}