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.
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