ACTG A5030: VALGANCICLOVIR FOR PRE-EMPTIVE THERAPY FOR CYTOMEGALOVIRUS (AIDS)

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。这是一项前瞻性、随机、双盲的III期临床试验，在有CMV发病风险的hiv感染患者中进行预防性口服缬更昔洛韦。本研究的主要目的是：1.评估口服缬更昔洛韦预防CMV终器官损伤（EOD）发展和/或高危人群死亡的有效性（通过筛查血浆CMV DNA阳性）；2.)在筛查血浆CMV DNA阳性的高危人群中，评价预防性缬更昔洛韦预防CMV EOD发生的安全性。次要目的：1.评价和比较两组巨细胞病毒EOD的病程；2.)研究期间口服缬更昔洛韦对血液CMV DNA、CD4细胞绝对计数、血浆HIV RNA水平、CMV特异性细胞免疫反应的影响，以及这些变量与CMV EOD发生风险的关系；3.)评估高危hiv感染者口服缬更昔洛韦预防性治疗巨细胞病毒病的成本和成本-效果；4)评估预防性口服缬更昔洛韦对受试者报告的生活质量的影响。第三个目的是评估口服缬更昔洛韦对巨细胞病毒EOD患者巨细胞病毒耐药突变的影响。

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. The primary objectives are 1.) to evaluate the effectiveness of pre-emptive oral valganciclovir in preventing CMV end organ damage (EOD) development and/or death in high-risk subjects identified by screening for plasma CMV DNA positivity; 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. Secondary objectives are 1.) to evaluate and compare the course of CMV EOD in the two treatment groups; 2.)to correlate the effect of oral valganciclovir on blood CMV DNA, absolute CD4 cell count, plasma HIV RNA level, CMV-specific cellular immune responses, and the relationship of these variables to the risk of developing CMV EOD during the study; 3.) to evaluate the costs and cost-effectiveness of a strategy of pre-emptive oral valganciclovir therapy for CMV disease in high-risk HIV-infected subjects; 4.)to evaluate the impact of pre-emptive oral valganciclovir on subject-reported quality of life. A tertiary objective is to evaluate the effect of oral valganciclovir on the development of CMV drug resistance mutations in subjects who develop CMV EOD.