ACTG A5150

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项前瞻性观察性研究旨在描述产后24周内产后病毒反弹的发生率、程度、机制和后果。妇女将在孕龄22周但小于30周时入组，以便获得反映稳定抗逆转录病毒治疗效果的产前病毒载量。本研究将通过监测依从性、亚组受试者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。本研究还将量化产前和产后的前病毒DNA，以排除体积收缩作为产后病毒载量增加的病因机制，并评估产前hiv特异性细胞毒性t淋巴细胞（CTL）反应是否会降低产后病毒反弹的可能性。血浆HIV-1 RNA和CDR+细胞计数将实时进行，而HIV-1基因分型、表型分型、HLA分型和CTL分析的样本将被保存以备以后分析。产后随访分别在产后2周、6周、12周和24周进行，之后每12周随访一次，共随访96周。主要目的是估计与妊娠晚期相比，产后24周出现病毒反弹的妇女比例。

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.