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 randomized, phase III, double-blind, placebo-controlled study will include approximately 134 patients from hospitals in the U.S. and in Europe, with approximately 5-10 enrolled at this UAB site. One of the purposes of this clinical trial is to determine if receiving valzcyclovir reduces brain and nervous system damage or if it can increase the survival of patients with HSE. Another purpose is to show that valacyclovir is safe to give to patients with herpes simplex encephalitis (HSE) after they have received IV acyclovir. Treatment with acyclovir is known to increase the chance that a patient will survive this disease. However, 20% of patients with HSE die and 60% have long-term brain damage, even if they receive acyclovir. This study is being done to determine if it is beneficial to treat HSE patients with the oral drug valacyclovir. Valacyclovir is a form of acyclovir that can be taken by mouth. Valacyclovir has been approved by the Food and Drug Administration (FDA) for treatment of other herpes simplex virus infections and for shingles, but it has not been studied or approved for HSE. There are two sub-studies included with this trial - one is the HSE neurological sub-study and the other is the HSE pharmacokinetic sub-study. The GCRC provides the ideal platform to accomplish this clinical investigation with the lab, inpatient, and outpatient facilities.
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