{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Currier J"],"funding":["NIAID NIH HHS"],"pagination":["349-57"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC3056066"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["153(6)"],"pubmed_abstract":["<h4>Background</h4>Women account for an increasing proportion of patients with HIV-1 but remain underrepresented in antiretroviral clinical trials.<h4>Objective</h4>To evaluate sex-based differences in efficacy and adverse events in treatment-experienced, HIV-positive women and men receiving darunavir-ritonavir therapy over 48 weeks.<h4>Design</h4>Multicenter, open-label, phase 3b study designed to enroll a high proportion of women, with sample size determined on the basis of a noninferiority design with a maximum allowable difference of 15% in virologic response favoring men. (ClinicalTrials.gov registration number: NCT00381303)<h4>Setting</h4>65 sites in the United States, Puerto Rico, and Canada.<h4>Patients</h4>287 women and 142 men.<h4>Intervention</h4>Patients received darunavir-rito"],"journal":["Annals of internal medicine"],"pubmed_title":["Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial."],"pmcid":["PMC3056066"],"funding_grant_id":["K24 AI56933","K24 AI056933"],"pubmed_authors":["Hanna B","Elion RA","Saag MS","Pollard RB","Squires K","Kanter TJ","Kumar P","Rawlings MK","Cadden J","Thompson MA","Myers RA","Martorell CT","Casey KK","Davis C","Haas DW","Brar I","Aberg JA","Falcon R","Rachlis A","Race E","Hagins D","Barker DE","Morales Ramirez J","Averitt Bridge D","Diaz L","Garcia F","Currier J","Albrecht MA","Presti RM","Clark R","Jayaweera DT","Patterson KB","Carpio-Cedraro FF","Hicks CB","Townsend G","Wright DP","Smaill F","Ryan R","Tedaldi EM","Tsoukas CM","Gathe JC","Osiyemi OO","Scribner AR","Hagins DP","Workowski K","Ramgopal M","Pegram PS","Ortiz R","Puga AM","Santiago S","Zorrilla CD","Clough L","Burdge D","Kadlecik P","Wade BH","Condoluci DV","Goulston C","Witt M","Tennenberg A","Bullock D","Smith K","Mrus J","Catalla R","Sepulveda-Arzola GE","GRACE (Gender, Race, And Clinical Experience) Study Group","Hodder S","Feinberg J","Skolnik PR","Yin M","Lennox JL","Smith SM"],"additional_accession":[]},"is_claimable":false,"name":"Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial.","description":"<h4>Background</h4>Women account for an increasing proportion of patients with HIV-1 but remain underrepresented in antiretroviral clinical trials.<h4>Objective</h4>To evaluate sex-based differences in efficacy and adverse events in treatment-experienced, HIV-positive women and men receiving darunavir-ritonavir therapy over 48 weeks.<h4>Design</h4>Multicenter, open-label, phase 3b study designed to enroll a high proportion of women, with sample size determined on the basis of a noninferiority design with a maximum allowable difference of 15% in virologic response favoring men. (ClinicalTrials.gov registration number: NCT00381303)<h4>Setting</h4>65 sites in the United States, Puerto Rico, and Canada.<h4>Patients</h4>287 women and 142 men.<h4>Intervention</h4>Patients received darunavir-rito","dates":{"release":"2010-01-01T00:00:00Z","publication":"2010 Sep","modification":"2026-04-30T05:27:13.54Z","creation":"2019-03-27T00:39:35Z"},"accession":"S-EPMC3056066","cross_references":{"pubmed":["20855799"],"doi":["10.7326/0003-4819-153-6-201009210-00002","10.1059/0003-4819-153-6-201009210-00002"]}}