中国艾滋病性病2024,Vol.30Issue(9) :983-987.DOI:10.13419/j.cnki.aids.2024.09.21

艾滋病免疫功能重建不全者治疗药物临床试验设计的关键考量

Key consideration on the clinical trial design of therapeutic drugs for immunological non-responder with AIDS

何春俐 赵建中
中国艾滋病性病2024,Vol.30Issue(9) :983-987.DOI:10.13419/j.cnki.aids.2024.09.21

艾滋病免疫功能重建不全者治疗药物临床试验设计的关键考量

Key consideration on the clinical trial design of therapeutic drugs for immunological non-responder with AIDS

何春俐 1赵建中1
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作者信息

  • 1. 国家药品监督管理局药品审评中心,北京 100076
  • 折叠

摘要

随着cART的广泛应用,大部分HIV感染者体内病毒得到控制,有效延缓了疾病进展,使HIV感染从一种致命性疾病变为可治疗的慢性疾病.但达到病毒学抑制后,部分患者CD4细胞恢复不佳,不能完全实现免疫重建,其机会性感染、非艾滋病并发症和肿瘤等的发病率和病死率均更高.针对艾滋病免疫功能重建不全的治疗,目前已有多个新药进入临床研发阶段,但国内外尚无相关临床试验技术指导原则.本文通过综述免疫功能重建不全者治疗药物的临床试验概况,对临床试验重点关注的要素进行讨论,包括试验设计、试验人群、主要疗效指标、治疗周期等,以期为药物临床研发提供参考.

Abstract

With the widespread application of combination antiretroviral therapy(cART),the majority of HIV-infected individuals have achieved viral control,effectively prevented disease progression.Nowadays,HIV infection has been transformed from a fatal disease into a chronic disease.However,following the attainment of virological suppression,a subset of patients exhibits inadequate recovery of CD4+T cells,and can not achieve immunological response,which results in higher incidences and mortality rates associated with opportunistic infections,non-AIDS-related complications,and malignancies.In response to the challenge of incomplete immune reconstitution,several novel therapeutic agents are currently undergoing clinical development.Nevertheless,there exists a lack of clinical trial guidances both domestically and internationally.This paper reviews the landscape of clinical trials evaluating therapies for immunological non-responder,discussing key elements of clinical trial design,trail population,primary efficacy variable,treatment period,etc.,with the aim of providing insights to inform the clinical development of these drugs.

关键词

艾滋病病毒/艾滋病/免疫功能重建不全者/免疫无应答者/临床试验

Key words

HIV/AIDS/immunological non-responder/clinical trial

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出版年

2024
中国艾滋病性病
中国性病艾滋病防治协会

中国艾滋病性病

CSTPCDCSCD北大核心
影响因子:1.292
ISSN:1672-5662
参考文献量1
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