Off Study Report in Surveillance Monitoring for ART Toxicities Study in HIV-uninfected Children Born to HIV-infected Women, PH100

Off study, with date and reason
Study Description
The PHACS Surveillance Monitoring for ART Toxicities (SMARTT) Study was designed to identify potential adverse effects of ARV exposures in infants born to women with HIV infection, and to evaluate associations with ARV combinations and specific ARV drugs in order to help inform treatment guidelines for HIV-infected pregnant women. SMARTT follows two cohorts of HIV- and ART-exposed but uninfected children: the Static and Dynamic cohorts. Domains of interest include birth outcomes, growth, metabolic, cardiac, neurological, neurodevelopmental, behavior, language, and hearing. Biospecimens are available. SMARTT participants include a Static cohort (n=1240) enrolled at age 1-12 years, a Dynamic cohort (n=1016) enrolled during gestation or < 1 week after birth, and a Reference cohort (n=239) of 50-60 children enrolled at each of ages 1, 3, 5, and 9 years.

研究终止说明：包含终止日期与原因

研究概况
PHACS抗逆转录病毒治疗毒性监测研究（SMARTT Study，全称Surveillance Monitoring for ART Toxicities Study）旨在识别人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）感染女性所分娩婴儿暴露于抗逆转录病毒药物（Antiretroviral, ARV）后的潜在不良事件，并评估不同ARV联合方案与特定ARV药物之间的关联，以期为HIV感染孕妇的临床治疗指南提供参考依据。

本研究对暴露于HIV与ARV但自身未感染的儿童设置两类核心随访队列：静态队列与动态队列。研究关注的领域涵盖分娩结局、生长发育、代谢状况、心脏功能、神经系统状态、神经发育水平、行为表现、语言能力与听力水平。本研究留存有生物标本。

SMARTT研究的纳入对象包含三类队列：静态队列（样本量n=1240，于儿童1~12岁时入组）、动态队列（样本量n=1016，于孕妇妊娠期或儿童出生后1周内入组），以及参考队列（总样本量n=239，分别在儿童1、3、5、9岁四个年龄段各纳入50~60名儿童）。