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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00031486
Phase
PHASE3
Status
Completed

Conditions

  • Encephalitis

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2000
Status verified
Oct 2011
Primary completion
Jun 30, 2010
Completion
Feb 28, 2011

Study Design

Enrollment
91 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Valacyclovir
  • Placebo Comparator: Placebo

Primary Outcome Measure

Survival With no or Mild Neuropsychological Impairment at 12 Months After Initiation of Study Medication as Measured by the Mattis Dementia Rating Scale (MDRS) [ Time Frame: One year post therapy. ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-2050-
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute - PhoenixPhoenixArizona85013-
University of California Davis Medical CenterSacramentoCalifornia95817-
University of ColoradoDenverColorado80220-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
University of Kansas Medical CenterKansas CityKansas66160-
Tulane University Health Sciences CenterNew OrleansLouisiana70112-
Johns Hopkins UniversityBaltimoreMaryland21287-
Mayo ClinicRochesterMinnesota55905-
Saint Louis University Hospital - School of Medicine - Department of Neurology & PsychiatrySt LouisMissouri63110-0250-
University of New MexicoAlbuquerqueNew Mexico87131-
University of ToledoToledoOhio43614-
University of Virginia Health SystemCharlottesvilleVirginia22908-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALSt. Joseph's Hospital and Medical Center - Barrow Neurological Institute - Phoenix· Phoenix, AZUniversity of California Davis Medical Center· Sacramento, CAUniversity of Colorado· Denver, CONorthwestern University Feinberg School of Medicine· Chicago, ILUniversity of Kansas Medical Center· Kansas City, KS

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