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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 Oct 23, 2026, 1:46 PM 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
Sep 2000 (Type not available)
Primary completion
Jun 2010 (Actual)
Completion
Feb 2011 (Actual)
Last update posted
Jun 12, 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 12, 2012 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00031486 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →