Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
This study involves patients 12 years and older who have been diagnosed with herpes simplex
encephalitis (HSE) by a specific laboratory test and have completed treatment or are being
treated with intravenous (given through a needle inserted into a vein) acyclovir. The purpose
of the study is to determine if treatment with 4 tablets, 500 milligrams each, of
valacyclovir given 3 times daily by mouth for 90 days is both effective and safe after
completing intravenous acyclovir treatment and if it can increase survival with or without
mild impairment of the brain and mental functions. Participants will be assigned to either
drug or placebo (inactive substance) randomly (by chance). Study procedures will include
blood samples and lumbar punctures (procedure in which a needle is inserted into the lower
back to collect cerebral spinal fluid). Subjects will participate for up to 24 months.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)