Ethical issues in establishing the efficacy and safety of long-acting injectable pre-exposure prophylaxis for HIV prevention: the HPTN 083 trial

被引：3
|
作者：
Sugarman, Jeremy [1 ,2 ]
Donnell, Deborah J. [3 ]
Hanscom, Brett [3 ]
McCauley, Marybeth [4 ]
Grinsztejn, Beatriz [5 ]
Landovitz, Raphael J. [6 ]
机构：
[1] Johns Hopkins Univ, Berman Inst Bioeth, Baltimore, MD 21205 USA
[2] Johns Hopkins Univ, Dept Med, Baltimore, MD USA
[3] Fred Hutchison Canc Res Ctr, Vaccine & Infect Dis Div, Seattle, WA USA
[4] HIV Prevent Trials Network Leadership & Operat Ct, Washington, DC USA
[5] Inst Nacl Infectol Evandro Chagas, Rio De Janeiro, Brazil
[6] UCLA, Ctr Clin AIDS Res & Educ, Los Angeles, CA USA
来源：
LANCET HIV | 2021年 / 8卷 / 11期
基金：
美国国家卫生研究院;
关键词：
PROTECTS MACAQUES; CABOTEGRAVIR;
D O I：
10.1016/S2352-3018(21)00153-3
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
Two multinational clinical trials have shown safety and efficacy of long-acting injectable cabotegravir for HIV preexposure prophylaxis (PrEP). These results will alter the landscape of HIV prevention and related research. Nevertheless, designing and conducting this research involved several ethical issues. This Viewpoint describes how we managed ethical issues over the duration of one of these trials (HPTN 083). Specifically, we discuss the rationale for pursuing a long-acting injectable agent in the presence of effective oral PrEP, trial design choices, site selection and local standards of prevention, data monitoring and early stopping, effects of the COVID-19 pandemic, post-trial access, and assessment of long-term safety.
引用
收藏
页码：E723 / E728
页数：6
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