Two multinational clinical trials have shown safety and efficacy of long-acting injectable cabotegravir for HIV pre-exposure 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.

两项多国临床试验表明长效可注射卡博特拉韦用于 HIV 暴露前预防 (PrEP) 的安全性和有效性。这些结果将改变艾滋病毒预防和相关研究的格局。然而，设计和进行这项研究涉及几个伦理问题。本观点描述了我们在其中一项试验期间如何管理伦理问题 (HPTN 083)。具体来说，我们讨论了在存在有效口服 PrEP、试验设计选择、地点选择和当地预防标准、数据监测和早期停止、COVID-19 大流行的影响、试验访问和长期安全性评估。