Department of Neurology, Yale University, New Haven, CT.
SEARCH, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
J Acquir Immune Defic Syndr. 2018 Oct 1;79(2):244-248. doi: 10.1097/QAI.0000000000001780.
Latent HIV reservoirs are rapidly established in lymphoid tissues during acute HIV infection (AHI). Sampling these tissues provides important information about HIV pathogenesis. This period is associated with viral replication and immune activation that may affect procedure-related adverse events (AEs). We examined the safety and tolerability of inguinal lymph node (LN) biopsy in research participants with AHI in Bangkok, Thailand.
Between 2013 and 2016, 67 AHI participants in the RV254/SEARCH010 study underwent at least one optional inguinal LN biopsy during AHI at the baseline visit and/or after antiretroviral therapy (median 48 weeks after antiretroviral therapy). Biopsy-related AEs were graded according to NIH Division of AIDS guidelines. Poisson regression was used to calculate incidence rate ratios and 95% confidence intervals to evaluate associations of demographic and HIV characteristics, procedure timing, and repetition with AE incidence.
Of the 67 participants, 97% were male with a median age of 26. Among 78 LN biopsies (39 at baseline and 39 at follow-up), 10 (12.8%) AEs were reported: 6 (7.7%) grade 1 and 4 (5.1%) grade 2. The AEs were biopsy-site discomfort (n = 8, 10.2%) and hematoma (n = 2, 2.6%). No factors were significantly associated with AE incidence. All biopsy-related AEs were transient and self-limited.
Inguinal LN biopsies were safe and well tolerated in mostly Thai men with AHI. As LN biopsies become an integral part of HIV research, this study provides information to participants, researchers, and institutional review boards that these samples can be safely obtained.
潜伏的 HIV 储库在急性 HIV 感染 (AHI) 期间迅速在淋巴组织中建立。对这些组织进行采样可提供有关 HIV 发病机制的重要信息。在此期间,病毒复制和免疫激活与程序相关的不良事件 (AE) 有关。我们在泰国曼谷研究了 AHI 患者进行腹股沟淋巴结 (LN) 活检的安全性和耐受性。
在 2013 年至 2016 年期间,RV254/SEARCH010 研究中的 67 名 AHI 参与者在基线访视和/或抗逆转录病毒治疗后 (抗逆转录病毒治疗后中位数为 48 周) 进行了至少一次可选的腹股沟 LN 活检。根据 NIH 艾滋病司指南对活检相关 AE 进行分级。使用泊松回归计算发病率比和 95%置信区间,以评估人口统计学和 HIV 特征、程序时机和重复与 AE 发生率的关联。
在 67 名参与者中,97%为男性,中位年龄为 26 岁。在 78 次 LN 活检中(基线 39 次,随访 39 次),报告了 10 次 (12.8%) AE:6 次 (7.7%) 为 1 级,4 次 (5.1%) 为 2 级。AE 为活检部位不适 (8 例,10.2%) 和血肿 (2 例,2.6%)。没有因素与 AE 发生率显著相关。所有与活检相关的 AE 均为短暂和自限性的。
在大多为泰国男性的 AHI 患者中,腹股沟 LN 活检是安全且耐受良好的。随着 LN 活检成为 HIV 研究的重要组成部分,本研究为参与者、研究人员和机构审查委员会提供了信息,表明可以安全地获取这些样本。