biostudies-literatureCurrier JNIAID NIH HHS349-57https://www.ebi.ac.uk/biostudies/studies/S-EPMC3056066biostudies-literatureUnknown153(6)<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-ritoAnnals of internal medicineSex-based outcomes of darunavir-ritonavir therapy: a single-group trial.PMC3056066K24 AI56933K24 AI056933Hanna BElion RASaag MSPollard RBSquires KKanter TJKumar PRawlings MKCadden JThompson MAMyers RAMartorell CTCasey KKDavis CHaas DWBrar IAberg JAFalcon RRachlis ARace EHagins DBarker DEMorales Ramirez JAveritt Bridge DDiaz LGarcia FCurrier JAlbrecht MAPresti RMClark RJayaweera DTPatterson KBCarpio-Cedraro FFHicks CBTownsend GWright DPSmaill FRyan RTedaldi EMTsoukas CMGathe JCOsiyemi OOScribner ARHagins DPWorkowski KRamgopal MPegram PSOrtiz RPuga AMSantiago SZorrilla CDClough LBurdge DKadlecik PWade BHCondoluci DVGoulston CWitt MTennenberg ABullock DSmith KMrus JCatalla RSepulveda-Arzola GEGRACE (Gender, Race, And Clinical Experience) Study GroupHodder SFeinberg JSkolnik PRYin MLennox JLSmith SMfalseSex-based outcomes of darunavir-ritonavir therapy: a single-group trial.<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-rito2010-01-01T00:00:00Z2010 Sep2026-04-30T05:27:13.54Z2019-03-27T00:39:35ZS-EPMC30560662085579910.7326/0003-4819-153-6-201009210-0000210.1059/0003-4819-153-6-201009210-00002