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Completed Phase 3 Interventional Results available

Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir

ClinicalTrials.gov ID: NCT00031486

Public ClinicalTrials.gov record NCT00031486. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 4:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00031486
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
91 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2000
Primary completion
May 31, 2010
Completion
Jan 31, 2011
Last update posted
Jun 11, 2012

2000 – 2011

United States locations

U.S. sites
13
U.S. states
13
U.S. cities
13
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294-2050
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute - Phoenix Phoenix Arizona 85013
University of California Davis Medical Center Sacramento California 95817
University of Colorado Denver Colorado 80220
Northwestern University Feinberg School of Medicine Chicago Illinois 60611
University of Kansas Medical Center Kansas City Kansas 66160
Tulane University Health Sciences Center New Orleans Louisiana 70112
Johns Hopkins University Baltimore Maryland 21287
Mayo Clinic Rochester Minnesota 55905
Saint Louis University Hospital - School of Medicine - Department of Neurology & Psychiatry St Louis Missouri 63110-0250
University of New Mexico Albuquerque New Mexico 87131
University of Toledo Toledo Ohio 43614
University of Virginia Health System Charlottesville Virginia 22908

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00031486, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 11, 2012 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00031486 live on ClinicalTrials.gov.

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