HIV 感染妇女所生的 HIV 未感染儿童的 ART 毒性研究监测 (SMARTT)
2025年6月26日 更新者：Paige Williams、Harvard School of Public Health (HSPH)
SMARTT 将估计可能与子宫内暴露于抗逆转录病毒疗法和/或感染 HIV 的母亲所生儿童在出生后头两个月内暴露相关的病症和诊断的发生率。
研究概览
地位
完全的
条件
详细说明
许多给予孕妇的抗逆转录病毒疗法 (ART) 药物会穿过胎盘，并可在羊水和脐带血中检测到，从而导致大量胎儿暴露。 因此，人们担心药物对胎儿和婴儿的毒性。 值得注意的是，目前批准的用于预防 HIV 母婴传播的 ART 药物均不属于食品和药物管理局 (FDA) 妊娠类别 A（在充分控制的人体研究中未确定胎儿风险）。 因此，需要继续检查 ART 在 HIV 传播预防中的毒性，以了解新型药物和组合的短期毒性以及长期毒性和细微不良反应的未解问题。
该研究将使用登记方法对入组时 12 岁以下的儿童进行主动监测。 将在多个领域寻找子宫内和/或出生后头两个月 ART 暴露引起的异常情况，包括代谢、生长、心脏、神经、神经发育、行为、语言和听力。 将通过一系列评估检查临床和实验室数据是否存在异常：将确定不良事件 (AE) → 选定的 AE 将触发预定义的额外评估 → 重要观察将被定义为病例 → 将研究范围内的重要病例模式定义为信号。 这些感兴趣的事件的发生率将随着时间的推移和 ART 方案进行监测，并与可能暗示信号的历史数据进行比较。 一些信号可能可以使用现有和/或以前收集的数据进行测试，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 的目标是：
- 通过一个持续监测系统，评估未感染 HIV 的儿童中潜在的 ART 相关毒性的发生情况，这些儿童是感染 HIV 的母亲所生，无论是否在子宫内和/或出生后的头两个月接触过 ART，并比较这些毒性的发生与其他数据来源以及 ART 接触的结果；和
- 积极鼓励假设驱动的研究，以确认这些信号是由于子宫内和/或出生后头两个月的 ART 暴露所致。 请注意，这些研究的完整设计和执行可能超出了 SMARTT 研究的范围，但 SMARTT 将为之提供便利。
SMARTT 的具体目标是：
- 创建一个静态监测队列以扩展儿童领域特定数据的收集： 2) 以前参加过另一项经 SMARTT 协议主席批准的儿科 HIV/AIDS 队列研究，或 3) 以前没有参加过批准的研究，但病历中有同等数据；
- 创建一个动态监测队列来检查在子宫内和/或出生后头两个月新接触 ART 的儿童的特定领域数据；
- 创建一个年轻成人队列来研究以前参加静态和动态队列的 SMARTT 参与者的长期结果。
- 为定义可能 ART 毒性的“信号”的每个域确定一组“触发器”，并将这些信号的出现与先前收集的数据和 ART 暴露进行比较；和
- 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。
研究类型
观察性的
注册 (实际的)
5169
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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San Juan、波多黎各、00935
- University of Puerto Rico Medical Center
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San Juan、波多黎各、00936-8344
- San Juan Research Hospital
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama
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California
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La Jolla、California、美国、92093
- University of California San Diego
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Los Angeles、California、美国、90033
- University of Southern California
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Denver Health Sciences Center
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Florida
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Fort Lauderdale、Florida、美国、33316
- Children's Diagnostic & Treatment Center
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Jacksonville、Florida、美国、32209
- University of Florida Health Science Center
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Miami、Florida、美国、33136
- University of Miami
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Illinois
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Chicago、Illinois、美国、60612
- University of Illinois, Chicago
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Chicago、Illinois、美国、60614
- Ann and Robert H. Lurie Children's Hospital
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Louisiana
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New Orleans、Louisiana、美国、70112
- Tulane University Health Sciences Center
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland
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New Jersey
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Newark、New Jersey、美国、07101-1709
- Rutgers - New Jersey Medical School
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New York
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Bronx、New York、美国、10461
- Jacobi Medical Center
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Bronx、New York、美国、10457
- Bronx Lebanon Hospital Center
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Brooklyn、New York、美国、11203-2098
- SUNY Downstate Medical Center
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New York、New York、美国、10016
- New York University School of Medicine
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Stony Brook、New York、美国、11794
- SUNY Stony Brook
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104-4318
- Children's Hospital of Philadelphia
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Tennessee
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Memphis、Tennessee、美国、38105-2764
- St. Jude Children's Research Hospital
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Texas
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Houston、Texas、美国、77030-3498
- Baylor College of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
从临床环境中招募的 0 - < 12 岁的 HIV 感染母亲所生的儿童。
描述
纳入标准：
动态队列：
- 大于或等于妊娠 23 周的 HIV 暴露活胎儿或妊娠 22 周后出生的活婴儿。 暴露和未暴露于 ART 的婴儿将被招募。
- 任何由感染 HIV 的母亲所生的婴儿都可以在等待确定婴儿的 HIV 感染状况之前登记。 然而，被发现为 HIV 阳性的婴儿将停止参与研究，并将转诊至本研究之外的护理机构。 HIV 感染状况将使用 HIV 暴露儿童未感染诊断来确定。
- 如果暴露于 ART，则必须提供妊娠三个月的 ART 暴露数据。
- 出生前到小于 72 小时的年龄。
- 父母/法定监护人愿意为孩子参加学习提供书面许可。
- 亲生母亲在孩子初次入学时的入学意愿。
排除标准：
动态队列：
没有任何
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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静态队列 - 关闭注册和跟进
入学时未感染艾滋病毒的儿童 < 12 岁，由感染艾滋病毒的母亲所生
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动态队列
从出生前到 ≤ 72 小时登记的未感染 HIV 的儿童，其由感染 HIV 的母亲所生
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参考队列 - 关闭注册和跟进
母亲所生的未感染 HIV 的孩子 孩子出生时未感染 HIV 在研究访问时登记的年龄为 1、3、5 或 9 岁（± 3 个月）
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年轻成人队列 - 关闭注册和跟进
≥ 18 岁的前动态和静态队列参与者。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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神经异常
大体时间：每年出生到 5 岁；此后每半年一次，评估因儿童年龄而异。
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通过头围测量和医疗记录审查评估癫痫发作、小头畸形或其他神经系统诊断的记录临床诊断。
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每年出生到 5 岁；此后每半年一次，评估因儿童年龄而异。
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神经发育异常
大体时间：1、3、5、9 和 13 岁，评估因儿童年龄而异。
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通过以下神经发育测试进行评估：Bayley Screener、Bayley III、WPPSI-III、BASC-2、WASI、WISC-IV、BRIEF、WIAT II。
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1、3、5、9 和 13 岁，评估因儿童年龄而异。
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异常生长和代谢功能
大体时间：每年出生到 5 岁；此后每半年一次，评估因儿童年龄而异。
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通过测量身高、体重、三头肌皮褶厚度、中上臂围度测量值、胰岛素和葡萄糖以及空腹血脂进行评估。
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每年出生到 5 岁；此后每半年一次，评估因儿童年龄而异。
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心脏异常
大体时间：3-5 岁。
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通过使用超声心动图和血清生物标志物 (ProBNP) 进行评估。
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3-5 岁。
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听力障碍
大体时间：5 岁和满足听力/语言触发条件的所有年龄段的儿童。
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通过听力学家进行的听力学评估进行评估。
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5 岁和满足听力/语言触发条件的所有年龄段的儿童。
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语言障碍
大体时间：1、2、3、5 和 9 岁，评估因年龄而异。
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通过以下语言测试进行评估：MCDI、年龄和阶段交流量表、PPVT IV、Goldman Fristoe 2、Rice Wexler、TELD-3、TOLD-3、Woodcock、CELF IV。
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1、2、3、5 和 9 岁，评估因年龄而异。
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吸毒和性活动
大体时间：11、13、15 和 17 岁。
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性行为和物质使用的评估将使用音频计算机辅助调查仪器 (ACASI) 进行。
ACASI 使用计算机和录音，以便参与者听到（通过耳机）和看到（在屏幕上）每个问题和答复列表。
事实证明，使用 ACASI 可以最大限度地减少因采访者在场而导致的回答偏差。
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11、13、15 和 17 岁。
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器官功能异常
大体时间：出生一岁，以后每半年一次。
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通过测量脂肪酶、CPK、ALT、肌酐、葡萄糖、LDH、BUN、WBC、PMN、淋巴细胞、血小板或血红蛋白（≥ 3 级不良事件）进行评估。
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出生一岁，以后每半年一次。
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因身体状况不明而死亡
大体时间：年度的。
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通过尸检评估。
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年度的。
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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孕期使用母体物质
大体时间：入境参观。
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通过访谈、毒理学报告和胎粪测试获得。
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入境参观。
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Ellen Chadwick, M.D.、Ann & Robert H Lurie Children's hospital of Chicago
- 首席研究员：Paige L Williams、Harvard School of Public Health (HSPH)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Goodenough CJ, Patel K, Van Dyke RB; Pediatric HIV/AIDS Cohort Study (PHACS). Is There a Higher Risk of Mother-to-child Transmission of HIV Among Pregnant Women With Perinatal HIV Infection? Pediatr Infect Dis J. 2018 Dec;37(12):1267-1270. doi: 10.1097/INF.0000000000002084.
- Alperen J, Davidson J, Siminski S, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Utility of the National Death Index in Identifying Deaths in a Clinic-Based, Multisite Cohort: The Experience of the Pediatric HIV/AIDS Cohort Study. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):e37-e39. doi: 10.1097/QAI.0000000000001763. No abstract available.
- Caniglia EC, Patel K, Huo Y, Williams PL, Kapetanovic S, Rich KC, Sirois PA, Jacobson DL, Hernandez-Diaz S, Hernan MA, Seage GR 3rd; Pediatric HIVAIDS Cohort Study. Atazanavir exposure in utero and neurodevelopment in infants: a comparative safety study. AIDS. 2016 May 15;30(8):1267-78. doi: 10.1097/QAD.0000000000001052.
- Van Dyke RB, Chadwick EG, Hazra R, Williams PL, Seage GR 3rd. The PHACS SMARTT Study: Assessment of the Safety of In Utero Exposure to Antiretroviral Drugs. Front Immunol. 2016 May 23;7:199. doi: 10.3389/fimmu.2016.00199. eCollection 2016.
- Margossian R, Williams PL, Yu W, Jacobson DL, Geffner ME, DiMeglio LA, Van Dyke RB, Spector SA, Schuster GU, Stephensen CB, Miller TL, Lipshultz SE; Pediatric HIV/AIDS Cohort Study (PHACS). Markers of Bone Mineral Metabolism and Cardiac Structure and Function in Perinatally HIV-Infected and HIV-Exposed but Uninfected Children and Adolescents. J Acquir Immune Defic Syndr. 2019 Jun 1;81(2):238-246. doi: 10.1097/QAI.0000000000002007.
- Fulcher IR, Tchetgen Tchetgen EJ, Williams PL. Mediation Analysis for Censored Survival Data Under an Accelerated Failure Time Model. Epidemiology. 2017 Sep;28(5):660-666. doi: 10.1097/EDE.0000000000000687.
- Correia K, Williams PL. Estimating the Relative Excess Risk Due to Interaction in Clustered-Data Settings. Am J Epidemiol. 2018 Nov 1;187(11):2470-2480. doi: 10.1093/aje/kwy154.
- Correia K, Williams PL. A hierarchical modeling approach for assessing the safety of exposure to complex antiretroviral drug regimens during pregnancy. Stat Methods Med Res. 2019 Feb;28(2):599-612. doi: 10.1177/0962280217732597. Epub 2017 Oct 3.
- Zash RM, Williams PL, Sibiude J, Lyall H, Kakkar F. Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges. Expert Opin Drug Saf. 2016 Nov;15(11):1501-1513. doi: 10.1080/14740338.2016.1226281. Epub 2016 Sep 6.
- Bather JR, Horton NJ, Coull BA, Williams PL. The impact of correlated exposures and missing data on multiple informant models used to identify critical exposure windows. Stat Med. 2023 Apr 15;42(8):1171-1187. doi: 10.1002/sim.9664. Epub 2023 Jan 16.
- Tassiopoulos K, Read JS, Brogly S, Rich K, Lester B, Spector SA, Yogev R, Seage GR 3rd. Substance use in HIV-Infected women during pregnancy: self-report versus meconium analysis. AIDS Behav. 2010 Dec;14(6):1269-78. doi: 10.1007/s10461-010-9705-0.
- Griner R, Williams PL, Read JS, Seage GR 3rd, Crain M, Yogev R, Hazra R, Rich K; Pediatric HIV/AIDS Cohort Study. In utero and postnatal exposure to antiretrovirals among HIV-exposed but uninfected children in the United States. AIDS Patient Care STDS. 2011 Jul;25(7):385-94. doi: 10.1089/apc.2011.0068. Epub 2011 Jun 10.
- Crain MJ, Williams PL, Griner R, Tassiopoulos K, Read JS, Mofenson LM, Rich KC; Pediatric HIVAIDS Cohort Study. Point-of-care capillary blood lactate measurements in human immunodeficiency virus-uninfected children with in utero exposure to human immunodeficiency virus and antiretroviral medications. Pediatr Infect Dis J. 2011 Dec;30(12):1069-74. doi: 10.1097/INF.0b013e318234c886.
- Williams PL, Seage GR 3rd, Van Dyke RB, Siberry GK, Griner R, Tassiopoulos K, Yildirim C, Read JS, Huo Y, Hazra R, Jacobson DL, Mofenson LM, Rich K; Pediatric HIV/AIDS Cohort Study. A trigger-based design for evaluating the safety of in utero antiretroviral exposure in uninfected children of human immunodeficiency virus-infected mothers. Am J Epidemiol. 2012 May 1;175(9):950-61. doi: 10.1093/aje/kwr401. Epub 2012 Apr 6.
- Siberry GK, Williams PL, Mendez H, Seage GR 3rd, Jacobson DL, Hazra R, Rich KC, Griner R, Tassiopoulos K, Kacanek D, Mofenson LM, Miller T, DiMeglio LA, Watts DH; Pediatric HIV/AIDS Cohort Study (PHACS). Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. AIDS. 2012 Jun 1;26(9):1151-9. doi: 10.1097/QAD.0b013e328352d135.
- Watts DH, Williams PL, Kacanek D, Griner R, Rich K, Hazra R, Mofenson LM, Mendez HA; Pediatric HIV/AIDS Cohort Study. Combination antiretroviral use and preterm birth. J Infect Dis. 2013 Feb 15;207(4):612-21. doi: 10.1093/infdis/jis728. Epub 2012 Nov 29.
- Wilkinson JD, Williams PL, Leister E, Zeldow B, Shearer WT, Colan SD, Siberry GK, Dooley LB, Scott GB, Rich KC, Lipshultz SE; Pediatric HIVAIDS Cohort Study (PHACS). Cardiac biomarkers in HIV-exposed uninfected children. AIDS. 2013 Apr 24;27(7):1099-108. doi: 10.1097/QAD.0b013e32835cf21c.
- Sirois PA, Huo Y, Williams PL, Malee K, Garvie PA, Kammerer B, Rich K, Van Dyke RB, Nozyce ML; Pediatric HIVAIDS Cohort Study. Safety of perinatal exposure to antiretroviral medications: developmental outcomes in infants. Pediatr Infect Dis J. 2013 Jun;32(6):648-55. doi: 10.1097/INF.0b013e318284129a.
- Himes SK, Scheidweiler KB, Tassiopoulos K, Kacanek D, Hazra R, Rich K, Huestis MA; Pediatric HIV/AIDS Cohort Study. Development and validation of the first liquid chromatography-tandem mass spectrometry assay for simultaneous quantification of multiple antiretrovirals in meconium. Anal Chem. 2013 Feb 5;85(3):1896-904. doi: 10.1021/ac303188j. Epub 2013 Jan 14.
- Rice ML, Zeldow B, Siberry GK, Purswani M, Malee K, Hoffman HJ, Frederick T, Buchanan A, Sirois PA, Allison SM, Williams PL; Pediatric HIVAIDS Cohort Study (PHACS). Evaluation of risk for late language emergence after in utero antiretroviral drug exposure in HIV-exposed uninfected infants. Pediatr Infect Dis J. 2013 Oct;32(10):e406-13. doi: 10.1097/INF.0b013e31829b80ee.
- Malee KM, Mellins CA, Huo Y, Tassiopoulos K, Smith R, Sirois PA, Allison SM, Kacanek D, Kapetanovic S, Williams PL, Grant ML, Marullo D, Aidala AA; Pediatric HIVAIDS Cohort Study (PHACS). Prevalence, incidence, and persistence of psychiatric and substance use disorders among mothers living with HIV. J Acquir Immune Defic Syndr. 2014 Apr 15;65(5):526-34. doi: 10.1097/QAI.0000000000000070.
- Nozyce ML, Huo Y, Williams PL, Kapetanovic S, Hazra R, Nichols S, Hunter S, Smith R, Seage GR 3rd, Sirois PA; Pediatric HIVAIDS Cohort Study. Safety of in utero and neonatal antiretroviral exposure: cognitive and academic outcomes in HIV-exposed, uninfected children 5-13 years of age. Pediatr Infect Dis J. 2014 Nov;33(11):1128-33. doi: 10.1097/INF.0000000000000410.
- Williams PL, Crain MJ, Yildirim C, Hazra R, Van Dyke RB, Rich K, Read JS, Stuard E, Rathore M, Mendez HA, Watts DH; Pediatric HIV/AIDS Cohort Study. Congenital anomalies and in utero antiretroviral exposure in human immunodeficiency virus-exposed uninfected infants. JAMA Pediatr. 2015 Jan;169(1):48-55. doi: 10.1001/jamapediatrics.2014.1889.
- Lipshultz SE, Williams PL, Zeldow B, Wilkinson JD, Rich KC, van Dyke RB, Seage GR 3rd, Dooley LB, Kaltman JR, Siberry GK, Mofenson LM, Shearer WT, Colan SD; Pediatric HIVAIDS Cohort Study (PHACS). Cardiac effects of in-utero exposure to antiretroviral therapy in HIV-uninfected children born to HIV-infected mothers. AIDS. 2015 Jan 2;29(1):91-100. doi: 10.1097/QAD.0000000000000499.
- Rough K, Tassiopoulos K, Kacanek D, Griner R, Yogev R, Rich KC, Seage GR 3rd; Pediatric HIVAIDS Cohort Study. Dramatic decline in substance use by HIV-infected pregnant women in the United States from 1990 to 2012. AIDS. 2015 Jan 2;29(1):117-23. doi: 10.1097/QAD.0000000000000503.
- Himes SK, Wu JW, Jacobson DL, Tassiopoulos K, Hazra R, Kacanek D, Van Dyke RB, Rich KC, Siberry GK, Huestis MA; Pediatric HIVAIDS Cohort Study (PHACS). Meconium Tenofovir Concentrations and Growth and Bone Outcomes in Prenatally Tenofovir Exposed HIV-Uninfected Children. Pediatr Infect Dis J. 2015 Aug;34(8):851-7. doi: 10.1097/INF.0000000000000747.
- Himes SK, Huo Y, Siberry GK, Williams PL, Rice ML, Sirois PA, Frederick T, Hazra R, Huestis MA; Pediatric HIVAIDS Cohort Study. Meconium Atazanavir Concentrations and Early Language Outcomes in HIV-Exposed Uninfected Infants With Prenatal Atazanavir Exposure. J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):178-86. doi: 10.1097/QAI.0000000000000558.
- Himes SK, Tassiopoulos K, Yogev R, Huestis MA; Pediatric HIV/AIDS Cohort Study (PHACS). Antiretroviral Drugs in Meconium: Detection for Different Gestational Periods of Exposure. J Pediatr. 2015 Aug;167(2):305-11.e3. doi: 10.1016/j.jpeds.2015.04.062. Epub 2015 May 19.
- Marsit CJ, Brummel SS, Kacanek D, Seage GR 3rd, Spector SA, Armstrong DA, Lester BM, Rich K; Pediatric HIV/AIDS Cohort Studies Network. Infant peripheral blood repetitive element hypomethylation associated with antiretroviral therapy in utero. Epigenetics. 2015;10(8):708-16. doi: 10.1080/15592294.2015.1060389.
- Siberry GK, Jacobson DL, Kalkwarf HJ, Wu JW, DiMeglio LA, Yogev R, Knapp KM, Wheeler JJ, Butler L, Hazra R, Miller TL, Seage GR 3rd, Van Dyke RB, Barr E, Davtyan M, Mofenson LM, Rich KC; Pediatric HIV/AIDS Cohort Study. Lower Newborn Bone Mineral Content Associated With Maternal Use of Tenofovir Disoproxil Fumarate During Pregnancy. Clin Infect Dis. 2015 Sep 15;61(6):996-1003. doi: 10.1093/cid/civ437. Epub 2015 Jun 9.
- Kirmse B, Yao TJ, Hofherr S, Kacanek D, Williams PL, Hobbs CV, Hazra R, Borkowsky W, Van Dyke RB, Summar M. Acylcarnitine Profiles in HIV-Exposed, Uninfected Neonates in the United States. AIDS Res Hum Retroviruses. 2016 Apr;32(4):339-48. doi: 10.1089/AID.2015.0112. Epub 2016 Jan 19.
- Williams PL, Hazra R, Van Dyke RB, Yildirim C, Crain MJ, Seage GR 3rd, Civitello L, Ellis A, Butler L, Rich K; Pediatric HIV/AIDS Cohort Study. Antiretroviral exposure during pregnancy and adverse outcomes in HIV-exposed uninfected infants and children using a trigger-based design. AIDS. 2016 Jan 2;30(1):133-44. doi: 10.1097/QAD.0000000000000916.
- Guerra V, Leister EC, Williams PL, Starc TJ, Lipshultz SE, Wilkinson JD, Van Dyke RB, Hazra R, Colan SD. Long-Term Effects of In Utero Antiretroviral Exposure: Systolic and Diastolic Function in HIV-Exposed Uninfected Youth. AIDS Res Hum Retroviruses. 2016 Jul;32(7):621-7. doi: 10.1089/AID.2015.0281. Epub 2016 May 9.
- Jacobson DL, Patel K, Williams PL, Geffner ME, Siberry GK, DiMeglio LA, Crain MJ, Mirza A, Chen JS, McFarland E, Kacanek D, Silio M, Rich K, Borkowsky W, Van Dyke RB, Miller TL; Pediatric HIVAIDS Cohort Study. Growth at 2 Years of Age in HIV-exposed Uninfected Children in the United States by Trimester of Maternal Antiretroviral Initiation. Pediatr Infect Dis J. 2017 Feb;36(2):189-197. doi: 10.1097/INF.0000000000001387.
- Tassiopoulos K, Huo Y, Braun J, Williams PL, Smith R, Aschengrau A, Nichols S, Hazra R, Meyer WA, Knapp K, Deygoo NS, Seage Iii GR. Blood lead levels and neurodevelopmental function in perinatally HIV-exposed, uninfected children in a US-based longitudinal cohort study. AIDS Res Hum Retroviruses. 2017 Sep;33(9):919-928. doi: 10.1089/AID.2016.0265. Epub 2017 Mar 21.
- Jao J, Kacanek D, Williams PL, Geffner ME, Livingston EG, Sperling RS, Patel K, Bardeguez AD, Burchett SK, Chakhtoura N, Scott GB, Van Dyke RB, Abrams EJ; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol. Birth Weight and Preterm Delivery Outcomes of Perinatally vs Nonperinatally Human Immunodeficiency Virus-Infected Pregnant Women in the United States: Results From the PHACS SMARTT Study and IMPAACT P1025 Protocol. Clin Infect Dis. 2017 Sep 15;65(6):982-989. doi: 10.1093/cid/cix488.
- Rough K, Seage GR 3rd, Williams PL, Hernandez-Diaz S, Huo Y, Chadwick EG, Currier JS, Hoffman RM, Barr E, Shapiro DE, Patel K; PHACS and the IMPAACT P1025 Study Teams. Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine. N Engl J Med. 2018 Apr 26;378(17):1593-1603. doi: 10.1056/NEJMoa1701666.
- Jao J, Jacobson DL, Yu W, Borkowsky W, Geffner ME, McFarland EJ, Patel K, Williams PL, Miller T; Pediatric HIV/AIDS Cohort Study. A Comparison of Metabolic Outcomes Between Obese HIV-Exposed Uninfected Youth From the PHACS SMARTT Study and HIV-Unexposed Youth From the NHANES Study in the United States. J Acquir Immune Defic Syndr. 2019 Jul 1;81(3):319-327. doi: 10.1097/QAI.0000000000002018.
- Sudfeld CR, Jacobson DL, Rueda NM, Neri D, Mendez AJ, Butler L, Siminski S, Hendricks KM, Mellins CA, Duggan CP, Miller TL; Pediatric HIV/AIDS Cohort Study. Third Trimester Vitamin D Status Is Associated With Birth Outcomes and Linear Growth of HIV-Exposed Uninfected Infants in the United States. J Acquir Immune Defic Syndr. 2019 Jul 1;81(3):336-344. doi: 10.1097/QAI.0000000000002041.
- Wang Y, Brummel SS, Beilstein-Wedel E, Dagnall CL, Hazra R, Kacanek D, Chadwick EG, Marsit CJ, Chanock SJ, Savage SA, Poirier MC, Machiela MJ, Engels EA; Pediatric HIV/AIDS Cohort Study. Association between zidovudine-containing antiretroviral therapy exposure in utero and leukocyte telomere length at birth. AIDS. 2019 Nov 1;33(13):2091-2096. doi: 10.1097/QAD.0000000000002317.
- Purswani MU, Russell JS, Dietrich M, Malee K, Spector SA, Williams PL, Frederick T, Burchett S, Redmond S, Hoffman HJ, Torre P 3rd, Lee S, Rice ML, Yao TJ; Pediatric HIV/AIDS Cohort Study. Birth Prevalence of Congenital Cytomegalovirus Infection in HIV-Exposed Uninfected Children in the Era of Combination Antiretroviral Therapy. J Pediatr. 2020 Jan;216:82-87.e2. doi: 10.1016/j.jpeds.2019.09.025. Epub 2019 Oct 23.
- Williams PL, Yildirim C, Chadwick EG, Van Dyke RB, Smith R, Correia KF, DiPerna A, Seage GR 3rd, Hazra R, Crowell CS; Surveillance Monitoring for ART Toxicities (SMARTT) study of the Pediatric HIV/AIDS Cohort Study. Association of maternal antiretroviral use with microcephaly in children who are HIV-exposed but uninfected (SMARTT): a prospective cohort study. Lancet HIV. 2020 Jan;7(1):e49-e58. doi: 10.1016/S2352-3018(19)30340-6. Epub 2019 Nov 15.
- Powis KM, Huo Y, Williams PL, Kacanek D, Jao J, Patel K, Seage GR 3rd, Van Dyke RB, Chadwick EG; Pediatric HIV/AIDS Cohort Study (PHACS). Antiretroviral Prescribing Practices Among Pregnant Women Living With HIV in the United States, 2008-2017. JAMA Netw Open. 2019 Dec 2;2(12):e1917669. doi: 10.1001/jamanetworkopen.2019.17669.
- Pintye J, Huo Y, Kacanek D, Zhang K, Kuncze K, Okochi H, Gandhi M. Extent of In Utero Transfer of Tenofovir From Mother to Fetus: A Paired Analysis of Hair Specimens Collected at Birth From a Cohort in the United States. J Infect Dis. 2021 Feb 24;223(4):638-644. doi: 10.1093/infdis/jiaa398.
- Pintye J, Huo Y, Kacanek D, Zhang K, Kuncze K, Okochi H, Gandhi M; Pediatric HIV/AIDS Cohort Study (PHACS). Detectable HIV RNA in late pregnancy associated with low tenofovir hair levels at time of delivery among women living with HIV in the United States. AIDS. 2021 Feb 2;35(2):267-274. doi: 10.1097/QAD.0000000000002730.
- O'Brien BE, Williams PL, Huo Y, Kacanek D, Chadwick EG, Powis KM, Correia K, Haddad LB, Yee LM, Chakhtoura N, Dola C, Van Dyke RB; Pediatric HIV/AIDS Cohort Study (PHACS). Repeat Pregnancies Among US Women Living With HIV in the SMARTT Study: Temporal Changes in HIV Disease Status and Predictors of Preterm Birth. J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):346-354. doi: 10.1097/QAI.0000000000002445.
- Torre P Rd, Zeldow B, Yao TJ, Hoffman HJ, Siberry GK, Purswani MU, Frederick T, Spector SA, Williams PL. Newborn Hearing Screenings in Human Immunodeficiency Virus-Exposed Uninfected Infants. J AIDS Immune Res. 2016;1(1):102. Epub 2016 Sep 5.
- Rice ML, Russell JS, Frederick T, Purswani M, Williams PL, Siberry GK, Redmond SM, Hoffman HJ, Yao TJ; Pediatric HIV/AIDS Cohort Study (PHACS). Risk for Speech and Language Impairments in Preschool Age HIV-exposed Uninfected Children With In Utero Combination Antiretroviral Exposure. Pediatr Infect Dis J. 2018 Jul;37(7):678-685. doi: 10.1097/INF.0000000000001875.
- Miller TL, Jacobson DL, Somarriba G, Neri D, Kurtz-Vraney J, Graham P, Gillman MW, Landy DC, Siminski S, Butler L, Rich KC, Hendricks K, Ludwig DA; Pediatric HIV/AIDS Cohort Study. A multicenter study of diet quality on birth weight and gestational age in infants of HIV-infected women. Matern Child Nutr. 2017 Oct;13(4):e12378. doi: 10.1111/mcn.12378. Epub 2016 Nov 8.
- Williams PL, Huo Y, Rutstein R, Hazra R, Rough K, Van Dyke RB, Chadwick EG. Trends in Neonatal Prophylaxis and Predictors of Combination Antiretroviral Prophylaxis in US Infants from 1990 to 2015. AIDS Patient Care STDS. 2018 Feb;32(2):48-57. doi: 10.1089/apc.2017.0295.
- Jao J, Kacanek D, Yu W, Williams PL, Patel K, Burchett S, Scott G, Abrams EJ, Sperling RS, Van Dyke RB, Smith R, Malee K; Pediatric HIV/AIDS Cohort Study. Neurodevelopment of HIV-Exposed Uninfected Infants Born to Women With Perinatally Acquired HIV in the United States. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):213-219. doi: 10.1097/QAI.0000000000002318.
- Crowell CS, Williams PL, Yildirim C, Van Dyke RB, Smith R, Chadwick EG, Seage GR 3rd, Diperna A, Hazra R; Pediatric HIV/AIDS Cohort Study. Safety of in-utero antiretroviral exposure: neurologic outcomes in children who are HIV-exposed but uninfected. AIDS. 2020 Jul 15;34(9):1377-1387. doi: 10.1097/QAD.0000000000002550.
- Labuda SM, Huo Y, Kacanek D, Patel K, Huybrechts K, Jao J, Smith C, Hernandez-Diaz S, Scott G, Burchett S, Kakkar F, Chadwick EG, Van Dyke RB; Pediatric HIV/AIDS Cohort Study. Rates of Hospitalization and Infection-Related Hospitalization Among Human Immunodeficiency Virus (HIV)-Exposed Uninfected Children Compared to HIV-Unexposed Uninfected Children in the United States, 2007-2016. Clin Infect Dis. 2020 Jul 11;71(2):332-339. doi: 10.1093/cid/ciz820.
- Lin SH, Wang Y, Hartley SW, Karyadi DM, Lee OW, Zhu B, Zhou W, Brown DW, Beilstein-Wedel E, Hazra R, Kacanek D, Chadwick EG, Marsit CJ, Poirier MC, Brummel SS, Chanock SJ, Engels EA, Machiela MJ; Pediatric HIV/AIDS Cohort Study. In-utero exposure to zidovudine-containing antiretroviral therapy and clonal hematopoiesis in HIV-exposed uninfected newborns. AIDS. 2021 Aug 1;35(10):1525-1535. doi: 10.1097/QAD.0000000000002894.
- Jacobson DL, Neri D, Gaskins A, Yee L, Mendez AJ, Hendricks K, Siminski S, Zash R, Hyzy L, Jao J; Pediatric HIV/AIDS Cohort Study. Maternal anemia and preterm birth among women living with HIV in the United States. Am J Clin Nutr. 2021 Jun 1;113(6):1402-1410. doi: 10.1093/ajcn/nqaa441.
- Smith C, Huo Y, Patel K, Fetters K, Hegemann S, Burchett S, Van Dyke R, Weinberg A. Immunologic and Virologic Factors Associated With Hospitalization in Human Immunodeficiency Virus-Exposed, Uninfected Infants in the United States. Clin Infect Dis. 2021 Sep 15;73(6):1089-1096. doi: 10.1093/cid/ciab272.
- Yee LM, Kacanek D, Brightwell C, Haddad LB, Jao J, Powis KM, Yao TJ, Barr E, Broadwell C, Siminski S, Seage GR 3rd, Chadwick EG; Pediatric HIV/AIDS Cohort Study. Marijuana, Opioid, and Alcohol Use Among Pregnant and Postpartum Individuals Living With HIV in the US. JAMA Netw Open. 2021 Dec 1;4(12):e2137162. doi: 10.1001/jamanetworkopen.2021.37162.
- Yu W, Jacobson DL, Williams PL, Patel K, Geffner ME, Van Dyke RB, Kacanek D, DiMeglio LA, Jao J; Pediatric HIV/AIDS Cohort Study (PHACS). Growth patterns of uninfected children born to women living with perinatally versus nonperinatally acquired HIV. AIDS. 2022 Mar 15;36(4):593-603. doi: 10.1097/QAD.0000000000003136.
- Young MR, Broadwell C, Kacanek D, Chadwick EG, Jao J, Moscicki AB, Powis K, Tassiopoulos K, Yee LM, Haddad LB; Pediatric HIV/AIDS Cohort Study. Sexually Transmitted Infections in Pregnant People With Human Immunodeficiency Virus: Temporal Trends, Demographic Correlates, and Association With Preterm Birth. Clin Infect Dis. 2022 Dec 19;75(12):2211-2218. doi: 10.1093/cid/ciac321.
- Yee LM, Jacobson DL, Haddad LB, Jao J, Powis KM, Kacanek D, Zash R, DiPerna A, Chadwick EG; Pediatric HIV/AIDS Cohort Study. Evaluating the association of antiretroviral therapy and immune status with hypertensive disorders of pregnancy among people with HIV. AIDS. 2023 Sep 1;37(11):1715-1723. doi: 10.1097/QAD.0000000000003607. Epub 2023 May 23.
- Jao J, Kacanek D, Broadwell C, Jacobson DL, Chadwick EG, Williams PL, Powis KM, Haddad LB, Yee L; Pediatric HIV/AIDS Cohort Study. Gestational weight gain in persons with HIV in the United States. AIDS. 2023 May 1;37(6):883-893. doi: 10.1097/QAD.0000000000003454. Epub 2022 Dec 2.
- Shiau S, Jacobson DL, Huo Y, Kacanek D, Yee LM, Williams DB, Haddad LB, Serghides L, Powis K, Sperling RS, Williams PL, Jao J; Pediatric HIV/AIDS Cohort Study. Unique Profile of Inflammation and Immune Activation in Pregnant People With HIV in the United States. J Infect Dis. 2023 Mar 1;227(5):720-730. doi: 10.1093/infdis/jiac501.
- Yao TJ, Malee K, Zhang J, Smith R, Redmond S, Rice ML, Frederick T, Torre P, Mellins CA, Hoffman HJ, Williams PL. In Utero Antiretroviral Exposure and Risk of Neurodevelopmental Problems in HIV-Exposed Uninfected 5-Year-Old Children. AIDS Patient Care STDS. 2023 Mar;37(3):119-130. doi: 10.1089/apc.2022.0189. Epub 2023 Feb 24.
- Davtyan M, Kacanek D, Lee J, Berman C, Chadwick EG, Smith R, Salomon L, Frederick T; Pediatric HIV/AIDS Cohort Study. The role of internalised HIV stigma in disclosure of maternal HIV serostatus to children perinatally HIV-exposed but uninfected: a prospective study in the United States. J Int AIDS Soc. 2023 Oct;26 Suppl 4(Suppl 4):e26167. doi: 10.1002/jia2.26167.
- Davtyan M, Kacanek D, Lee J, Berman C, Chadwick EG, Smith R, Salomon L, Frederick T; Pediatric HIV/AIDS Cohort Study. Factors associated with internalized HIV-related stigma among biological mothers living with HIV enrolled in a US cohort study. AIDS Care. 2024 Feb;36(2):220-226. doi: 10.1080/09540121.2023.2263680. Epub 2024 Jan 30.
- Fisher SA, Jao JK, Yee LM, Serghides L, Chadwick EG, Jacobson DL. Association of Fatty Acid Signatures with HIV Viremia in Pregnancy. AIDS Res Hum Retroviruses. 2024 Apr;40(4):257-267. doi: 10.1089/AID.2023.0040. Epub 2023 Oct 30.
- Berhie S, Kacanek D, Lee J, Jao J, Powis K, Salomon L, Siddiqui D, Yee LM; Pediatric HIV/AIDS Cohort Study. Routine Vaccination During Pregnancy Among People Living With HIV in the United States. JAMA Netw Open. 2024 May 1;7(5):e249531. doi: 10.1001/jamanetworkopen.2024.9531.
- Fung K, Hernandez-Diaz S, Zash R, Chadwick EG, Van Dyke RB, Broadwell C, Jao J, Powis K, Yee LM, Williams PL; Pediatrics HIV/AIDS Cohort Study (PHACS). First-trimester exposure to newer antiretroviral agents and congenital anomalies in a US cohort. AIDS. 2024 Sep 1;38(11):1686-1695. doi: 10.1097/QAD.0000000000003955. Epub 2024 Jun 11.
- Purswani MU, Jacobson DL, DiMeglio LA, Yao TJ, Kopp JB, Van Dyke RB, Yu W, Siberry GK; Pediatric HIV/AIDS Cohort Study (PHACS). Phosphaturia in HIV-Exposed Uninfected Neonates Associated with Maternal Use of Tenofovir Disoproxil Fumarate in Late Pregnancy. J Pediatric Infect Dis Soc. 2024 Aug 24;13(8):396-405. doi: 10.1093/jpids/piae054.
- Gojanovich GS, Marsit CJ, Kacanek D, Russell J, Hudson G, Van Dyke RB, Naini AB, Gerschenson M; Pediatric HIV/AIDS Cohort Study. Relationships of mitochondrial DNA mutations and select clinical diagnoses in perinatally HIV- and ART-exposed uninfected children. Mitochondrion. 2024 Nov;79:101949. doi: 10.1016/j.mito.2024.101949. Epub 2024 Aug 30.
- Olivero R, Williams PL, Sawyer G, Yee LM, Patel K, Hernandez-Diaz S, Powis K, Paul M, Chadwick EG; Pediatric HIV/AIDS Cohort Study and the HOPE study. Birth outcomes following bictegravir exposure during pregnancy. AIDS. 2025 Mar 15;39(4):381-386. doi: 10.1097/QAD.0000000000004041. Epub 2024 Oct 14.
- Hermetet-Lindsay KD, Correia KF, Williams PL, Smith R, Malee KM, Mellins CA, Rutstein RM; Pediatric HIV/AIDS Cohort Study. Contributions of Disease Severity, Psychosocial Factors, and Cognition to Behavioral Functioning in US Youth Perinatally Exposed to HIV. AIDS Behav. 2017 Sep;21(9):2703-2715. doi: 10.1007/s10461-016-1508-5.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年3月1日
初级完成 (实际的)
2025年5月31日
研究完成 (实际的)
2025年5月31日
研究注册日期
首次提交
2011年3月4日
首先提交符合 QC 标准的
2011年3月4日
首次发布 (估计的)
2011年3月7日
研究记录更新
最后更新发布 (实际的)
2025年6月27日
上次提交的符合 QC 标准的更新
2025年6月26日
最后验证
2025年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 1P01HD103133 - PH100
- PH100 (其他标识符：PHACS Protocol Number)
- 1P01HD103133 (美国 NIH 拨款/合同)
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