CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 91 enrolled
Drug / intervention
Valacyclovir +1 moredrug
Likely dose
Valacyclovir 2 g (4 × 500 mg tablets) orally three times daily for 90 daysAI-extracted
Key inclusion· 6
  • ✓Documented herpes simplex encephalitis (HSE) with CSF or brain biopsy PCR-positive for HSV DNA
  • ✓Completed 14–21 days of IV acyclovir at 30–60 mg/kg/day (or renal-adjusted equivalent)
  • ✓Age ≥12 years
  • ✓Weight ≥45.5 kg (100 pounds)
Key exclusion· 6
  • ✕HSV meningitis only (without encephalitis)
  • ✕Creatinine clearance ≤50 ml/min/1.73 m²
  • ✕Life expectancy <90 days
  • ✕Prior anti-herpesvirus medications other than IV acyclovir for current HSE episode

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00031486
NCT00031486Phase 3Completed
CompareCT.gov

A Phase III Double-Blind, Placebo-Controlled Trial of Long Term Therapy of Herpes Simplex Encephalitis (HSE): An Evaluation of Valacyclovir (CASG-204)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 7, 2002·Updated Jun 12, 2012

In Brief

A Phase 3 clinical trial evaluating Valacyclovir and Placebo for Encephalitis. Completed, enrolled 91 participants across 21 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEncephalitis
CountriesCanada, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2002
Enrollment StartSep 1, 2000
Primary CompletionJun 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 24.3 years ago

Interventions

Valacyclovirdrug

Valacyclovir is a L-valyl ester of acyclovir. Valacyclovir is provided in 500 mg tablets, 4 tablets (500 mg tablets) 3 times a day (every 8 hours) for 90 days.

Placebodrug

Placebo (identical to active drug in appearance) 500 mg tablets, 4 tablets 3 times daily for 90 days.