Since the first HIV-cured person was reported in 2009, a strong interest in developing highly sensitive HIV and SIV reservoir assays has emerged. In particular, the question arose about the comparative value of state-of-the-art assays to measure and characterize the HIV reservoir, and how these assays can be applied to accurately detect changes in the reservoir during efforts to develop a cure for HIV infection. Second, it is important to consider the impact on the outcome of clinical trials if these relatively new HIV reservoir assays are incorporated into clinical trial endpoints and/or used for clinical decision-making. To understand the advantages and limitations and the regulatory implications of HIV reservoir assays, the National Institute of Allergy and Infectious Diseases (NIAID) sponsored and convened a meeting on September 16, 2022, to discuss the state of knowledge concerning these questions and best practices for selecting HIV reservoir assays for a particular research question or clinical trial protocol.

中文翻译：

---

当前用于临床前和临床应用的 HIV/SIV 储库测定：专家的建议 2022 年 NIAID 研讨会摘要。

自 2009 年报道第一例 HIV 治愈者以来，人们对开发高度敏感的 HIV 和 SIV 储存库检测方法产生了浓厚的兴趣。特别是，出现了关于测量和表征 HIV 病毒库的最先进检测方法的比较价值，以及在开发 HIV 感染治疗方法的过程中如何应用这些检测方法来准确检测病毒库的变化的问题。 。其次，重要的是要考虑如果这些相对较新的 HIV 储存库检测被纳入临床试验终点和/或用于临床决策，对临床试验结果的影响。为了了解 HIV 储存库检测的优点和局限性以及监管影响，美国国家过敏和传染病研究所 (NIAID) 于 2022 年 9 月 16 日主办并召开了一次会议，讨论有关这些问题的知识状况和最佳实践针对特定研究问题或临床试验方案选择 HIV 储存库检测。