ACTG A5030 VALGANCICLOVIR PRE-EMPTIVE THERAPY FOR CMV

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项第三阶段的前瞻性随机双盲口服伐更昔洛韦试验，用于有患巨细胞病毒病风险的HIV感染者。受试者是那些在研究期间由于CD4细胞数量低和可检测到的HIV病毒载量而有可能仍然处于CMV疾病风险中的患者。主要目标是：1)评估先发制人口服valganciclovir在通过血浆CMV DNA阳性筛查确定的高危受试者中预防CMV末端器官疾病(EOD)发展和/或死亡的有效性；以及2)评估先发制人Valganciclovir预防通过血浆CMV DNA阳性筛查确定的高危受试者发生CMV EOD的安全性。

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 is a phase III, prospective, randomized, double-blind trial of pre-emptive oral valganciclovir in subjects with HIV-infection at risk for developing CMV disease. Subjects are patients who are likely by virtue of their low CD4 cell count and detectable HIV viral load to remain at risk for CMV disease during the study. The primary objectives are 1) to evaluate the effectiveness of pre-emptive oral valganciclovir in preventing CMV end-organ disease (EOD) development and/or death in high-risk subjects identified by screening for plasma CMV DNA positivity; and 2) to evaluate the safety of pre-emptive valganciclovir for prevention of CMV EOD development in high-risk subjects identified by screening for plasma CMV DNA positivity.