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利用一项针对人类免疫缺陷病毒患者的主要心血管疾病预防的里程碑式试验:来自 REPRIEVE 共同主要研究者的介绍。

Leveraging a Landmark Trial of Primary Cardiovascular Disease Prevention in Human Immunodeficiency Virus: Introduction From the REPRIEVE Coprincipal Investigators.

机构信息

Metabolism Unit, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.

Division of Cardiology and Duke Clinical Research Center, Duke University School of Medicine, Durham, North Carolina, USA.

出版信息

J Infect Dis. 2020 Jul 9;222(Suppl 1):S1-S7. doi: 10.1093/infdis/jiaa098.

Abstract

The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus. Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents, REPRIEVE will assess the effects of a statin as a cardiovascular disease prevention strategy in people with HIV (PWH) receiving antiretroviral therapy (ART). Although the primary purpose of REPRIEVE, and its substudy assessing coronary plaque, is to assess cardiovascular outcomes, the trial is a rich source of data on population characteristics and critical comorbidities in PWH, particularly across Global Burden of Disease (GBD) regions, reflective of the ethnic, racial, and gender diversity in this global epidemic. The purpose of this Supplement is to leverage the rich phenotyping in REPRIEVE, to provide data on detailed patterns of baseline ART and immune function by GBD region, reproductive aging among cisgender women, and data on the participation and clinical characteristics of transgender participants. We also leveraged REPRIEVE to assess critical comorbidities, including renal dysfunction, muscle function and frailty, and myocardial steatosis. REPRIEVE is a remarkable collaboration between funders, trial networks, clinical research sites, clinical and data coordinating centers, and willing participants who devoted their time to make the trial possible.

摘要

HIV 血管事件预防随机试验(REPRIEVE)是最大规模的人类免疫缺陷病毒心血管疾病研究。该研究于 2015 年至 2019 年期间在五大洲的 7770 名参与者中进行,将评估他汀类药物作为接受抗逆转录病毒治疗(ART)的 HIV 感染者(PWH)心血管疾病预防策略的效果。尽管 REPRIEVE 及其评估冠状动脉斑块的子研究的主要目的是评估心血管结局,但该试验是 PWH 人群特征和关键合并症的丰富数据来源,特别是在全球疾病负担(GBD)区域,反映了这种全球流行疾病中的种族、民族和性别多样性。本增刊的目的是利用 REPRIEVE 中的丰富表型数据,按 GBD 区域提供基线 ART 和免疫功能的详细模式、顺性别女性的生殖衰老以及跨性别参与者的参与和临床特征数据。我们还利用 REPRIEVE 评估了关键合并症,包括肾功能障碍、肌肉功能和脆弱性以及心肌脂肪变性。REPRIEVE 是资助者、试验网络、临床研究站点、临床和数据协调中心以及愿意抽出时间使试验成为可能的参与者之间的一项非凡合作。

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