多肽类HIV-1融合抑制剂早期临床研究策略考虑要点  

Considerations on early clinical trial design for peptide-based HIV-1 fusion inhibitors

作　　者：杨琬秋 赵建中[2] 杨劲[1] Yang Wanqiu Zhao Jianzhong Yang Jin(Center of Drug Metabolism and Pharmacokinetics , China Pharmaceutical University, Nanjing 210009, China Center for Drug Evaluation, State Food and Drug Administration)

机构地区：[1]中国药科大学药物代谢动力学研究中心,南京210009 [2]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国艾滋病性病》2016年第12期1015-1018,1021,共5页Chinese Journal of Aids & STD

摘　　要：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-1fusion inhibitor is a new class of anti-HIV infection drugs following the reverse transcriptase and protease inhibitor.Enfuvirtide（T20）is the only HIV-1fusion inhibitor approved by the US FDA for clinical use.This article reviewed T20 early clinical trials for peptide-based HIV-1fusion inhibitors,and discussed the issues worthy of concerns during the early stages of clinical development according to the guidelines abroad,including intent-to-treat population,end point,dosage regimen,drug-drug interactions,modeling and simulation,early clinical study design and so on.We hope this review is useful for the researchers engaged in the development of new peptide-based HIV-1fusion inhibitor.

关 键 词：多肽类人类免疫缺陷病毒Ⅰ型融合抑制剂 恩夫韦肽 早期临床研究策略 

分 类 号：R373.9[医药卫生—病原生物学]