ACTG A5030 VALGANCICLOVIR PRE-EMPTIVE THERAPY FOR CMV

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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.