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Cardiac Conduction Safety during Coadministration of Artemether-Lumefantrine and Lopinavir/Ritonavir in HIV-Infected Ugandan Adults

机译:在受艾滋病毒感染的乌干达成年人中联合使用蒿甲醚-卢美他汀和洛匹那韦/利托那韦的心脏传导安全性

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Background. We aimed to assess cardiac conduction safety of coadministration of the CYP3A4 inhibitor lopinavir/ritonavir (LPV/r) and the CYP3A4 substrate artemether-lumefantrine (AL) in HIV-positive Ugandans.Methods. Open-label safety study of HIV-positive adults administered single-dose AL (80/400 mg) alone or with LPV/r (400/100 mg). Cardiac function was monitored using continuous electrocardiograph (ECG).Results. Thirty-two patients were enrolled; 16 taking LPV/r -based ART and 16 ART naïve. All took single dose AL. No serious adverse events were observed. ECG parameters in milliseconds remained within normal limits. QTc measurements did not change significantly over 72 hours although were higher in LPV/r arm at 24 (424 versus 406;P=.02) and 72 hours (424 versus 408;P=.004) after AL intake.Conclusion. Coadministration of single dose of AL with LPV/r was safe; however, safety of six-dose AL regimen with LPV/r should be investigated.
机译:背景。我们的目的是评估CYP3A4抑制剂洛匹那韦/利托那韦(LPV / r)和CYP3A4底物蒿甲醚-卢美他汀(AL)在HIV阳性乌干达人中共同给药的心脏传导安全性。艾滋病毒抗体阳性的成年人单独或单用LPV / r(400 /100μmg)服用单剂量AL(80 /400μmg)的开放标签安全性研究。使用连续心电图仪(ECG)监测心脏功能。入选了32例患者。 16位采用基于LPV / r的ART和16位朴素的ART。全部服用单剂量AL。没有观察到严重的不良事件。以毫秒为单位的ECG参数保持在正常范围内。 QTc测量值在72小时内没有显着变化,尽管LPV / r组在AL摄入后24小时(424对406; P = .02)和72小时(424对408; P = .004)较高。单剂量AL与LPV / r并用是安全的;但是,应研究六剂ALV与LPV / r方案的安全性。

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