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, double-blind, placebo-controlled, randomized study of the effect of pre-emptive treatment on the time-to CMV EOD. Subjects at risk for infection with CMV will be entered on Step 1 and followed with frequent CMV DNA PCR measurement. Approximately 150 subjects who develop a quantitatively positive CMV DNA results will be randomized to step 2 for treatment with oral valganciclovir or placebo. Assuming that 20% of subjects become CMV PCR positive, we estimate that 750 subjects should enter to step 1. We anticipate that the randomization of 150 subjects to Step 2 will be accomplished over 1.5 years with some lag between the initiation of accrual to step 1 and step 2. Subjects in step 1 with positive CMV DNA results will continue to enter step 2 until the study is closed even if the total number entering step 2 exceeds the projected 150. Subjects randomized to step 2 will be followed for the development of CMV EOD for additional one year after the entry of the 150th subjects on step 2. Subjects who develope CMV EOD will enter Step 3. Follow-up for step 3 will end concurrently with the end of follow-up on step 2. All subjects in all steps will be followed to a final closing date. This study will last a total of 2.5 years.
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