ACTG A5030 VALGANCICLOVIR PRE-EMPTIVE THERAPY FOR CMV

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来源获得了主要资金，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。这是一项III期、前瞻性、随机、双盲试验，在有发生CMV疾病风险的HIV感染受试者中进行先发制人的口服缬更昔洛韦。受试者是由于其低CD 4细胞计数和可检测的HIV病毒载量而可能在研究期间保持CMV疾病风险的患者。主要目的是：1）在通过筛查血浆CMV DNA阳性确定的高风险受试者中，评价预先口服缬更昔洛韦预防CMV终末器官疾病（EOD）发展和/或死亡的有效性; 2）在通过筛查血浆CMV DNA阳性确定的高风险受试者中，评价预先口服缬更昔洛韦预防CMV EOD发展的安全性。

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.