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艾滋病病毒1型(HIV-1)融合抑制剂是继反转录酶和蛋白酶抑制剂后的新一类抗HIV感染药物。恩夫韦肽(T20)是目前唯一一个经美国食品药品管理局(FDA)批准上市的HIV-1融合抑制剂。通过综述T20早期临床试验,获取其临床开发策略,并结合国外指导原则,对多肽类HIV-1融合抑制剂早期临床开发过程中需要关注的问题进行探讨。包括药物临床定位、效应指标的选择、给药方案的选择、相互作用的考察、建模与仿真的应用、早期临床研究设计方法等。期望对中国从事多肽类HIV-1融合抑制剂研发人员有所帮助。
HIV-1 fusion inhibitors are a new class of anti-HIV drugs following reverse transcriptase and protease inhibitors. Enfuvirtide (T20) is the only HIV-1 fusion inhibitor approved by the U.S. Food and Drug Administration (FDA). By reviewing the early clinical trials of T20 and obtaining its clinical development strategies, combined with the guiding principles abroad, the issues needing attention in the early clinical development of peptide-based HIV-1 fusion inhibitors were discussed. Including the clinical positioning of drugs, the choice of effect indicators, the choice of drug delivery protocols, the investigation of interactions, modeling and simulation applications, early clinical research design methods. It is hoped that it will be helpful for R & D personnel engaged in peptide HIV-1 fusion inhibitors in China.