ACTG A5150

ACTG A5150

• 批准号: 7380442
• 负责人: Laura Hinkle Bachmann
• 金额: $ 0.11万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380442
• 关键词: ACTG; A5150

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. This prospective observational study is designed to characterize the incidence, magnitude, mechanisms, and consequences of postpartum viral rebound during the initial 24 weeks postpartum. Women will be enrolled at >22 but <30 weeks gestational age such that prepartum viral loads can be obtained that reflect the effect of stable antiretroviral therapy. This study will explore the mechanism(s) of this viral rebound by monitoring changes in adherence, drug exposure in a subgroup of subjects, and genotype viral resistance. This study will also quantify proviral DNA pre-and post-partum to rule out volume contraction as an etiologic mechanism of postpartum viral load increases, and assess whether prepartum HIV-specific cytotoxic T-lymphocyte (CTL) responses decrease the likelihood of postpartum viral rebound. Plasma HIV-1 RNA and CDR+ cell counts will be performed in real time while samples for HIV-1 genotyping, phenotyping, HLA class typing and CTL assays will be stored for possible later analyses. Follow-up postpartum will occur at 2, 6, 12, and 24 weeks, then every 12 weeks for a total of 96 weeks postpartum. The primary objective is to estimate the proportion of women who develop viral rebound at 24 weeks postpartum compared with the third trimester.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这项前瞻性观察性研究旨在描述产后最初24周内产后病毒反弹的发生率，幅度，机制和后果。妇女将在>22但<30周胎龄时入组，以便可以获得反映稳定抗逆转录病毒疗法效果的胎盘病毒载量。本研究将通过监测依从性、受试者亚组的药物暴露和基因型病毒耐药性的变化来探索这种病毒反弹的机制。本研究还将定量产前和产后前病毒DNA，以排除产后病毒载量增加的病因机制是体积收缩，并评估产后HIV特异性细胞毒性T淋巴细胞（CTL）反应是否降低产后病毒反弹的可能性。将真实的实时进行血浆HIV-1 RNA和CDR+细胞计数，同时将储存用于HIV-1基因分型、表型分型、HLA类分型和CTL检测的样本，以备后续分析。产后随访将在第2、6、12和24周进行，然后每12周进行一次，共产后96周。 主要目的是估计与妊娠晚期相比，产后24周发生病毒反弹的妇女比例。