PHACS PH 100 SURVEILLANCE MONITORING FOR ART TOXICITIES STUDY IN HIV-UNINFEC

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 一项前瞻性队列研究，旨在估计HIV感染母亲所生儿童（来源人群）中可能与宫内暴露于抗逆转录病毒治疗和/或出生后头两个月暴露相关的疾病和诊断的发生率。 本研究将采用登记方法对入组时年龄< 12岁的儿童进行主动监测。 将在多个领域（包括代谢、生长、心脏、神经系统、神经发育、行为、语言和听力领域）中寻找子宫内和/或出生后前两个月内ART暴露导致的异常发生率。 将通过分级评价检查临床和实验室数据是否存在异常：是否识别不良事件（AE）？选定的AE将触发预定义的额外评价（重要观察结果将被定义为病例），重要研究范围内病例的模式将被定义为信号。 将通过ART方案监测这些关注事件的发生率，并与可能提示信号的历史数据进行比较。 一些信号可能是使用现有和/或以前收集的数据可测试的，而其他信号可能表明需要在SMARTT之外进行额外的假设驱动研究。 SMARTT研究将检查ART在预防艾滋病毒传播中的毒性，以了解新药物和组合的短期毒性以及长期毒性和微妙副作用的未回答问题。 SMARTT的具体目标是： 创建一个静态监测队列，以扩展先前入组WITS、PACTG 219 C、P1025和其他类似儿科队列研究的儿童的特定领域数据收集; 建立一个动态监测队列，以检查在子宫内和/或出生后头两个月内新接触抗逆转录病毒疗法的儿童的特定领域数据; 确定每个领域的一组“触发因素”，定义可能的ART毒性“信号”，并将这些信号的发生与先前收集的数据和ART暴露进行比较; 鼓励和促进假设驱动研究的发展，以评估“信号”是否是子宫内和/或生命头两个月ART暴露的结果。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Prospective cohort study designed to estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers (source population). The study will use a registry approach to conduct active surveillance among children < 12 years of age at enrollment. Occurrences of abnormalities from ART exposure in utero and/or in the first two months of life will be sought in multiple domains, including metabolic, growth, cardiac, neurologic, neurodevelopmental, behavior, language, and hearing domains. Clinical and laboratory data will be examined for abnormalities through a hierarchy of evaluations: adverse events (AE) will be identified ? selected AEs will trigger predefined additional evaluations (significant observations will be defined as cases) a pattern of significant study-wide cases will be defined as signals. The incidence of these events of interest will be monitored over time and by ART regimen, and compared with historical data that may be suggestive of a signal. Some signals may be testable using existing and/or previously collected data, while other signals may indicate the need for additional hypothesis-driven studies outside of SMARTT. The SMARTT study will examine the toxicity of ART in HIV transmission prevention for the short-term toxicity of newer agents and combinations as well as the unanswered questions of longer term toxicity and subtle adverse effects. The specific aims of SMARTT are: ¿To create a Static Surveillance Cohort to extend domain-specific data collection in children previously enrolled in WITS, PACTG 219C, P1025 and other similar pediatric cohort studies; ¿To create a Dynamic Surveillance Cohort to examine domain-specific data of children newly exposed to ART in utero and/or in the first two months of life; ¿To identify a set of "triggers" for each domain that define a "signal" of possible ART toxicity and compare the occurrence of these signals with previously collected data and by ART exposure; and ¿To encourage and facilitate the development of hypothesis-driven studies to evaluate whether a "signal" is the result of ART exposure in utero and/or in the first two months of life.