ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00031486
Recruitment Status : Completed
First Posted : March 7, 2002
Results First Posted : June 12, 2012
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Encephalitis
Interventions: Drug: Valacyclovir
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects enrolled in the study presented with findings of HSE.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients considered for enrollment are those who are receiving and will have completed IV Acyclovir for a minimum duration of 14 days to a maximum of 21 days at a minimum dose of 30 mg/kg/day to a maximum dose of 60 mg/kg/day.

Reporting Groups
  Description
Valacyclovir four 500 mg tablets 3 times a day for 90 days
Placebo four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days

Participant Flow:   Overall Study
    Valacyclovir   Placebo
STARTED   40   47 
COMPLETED   33   35 
NOT COMPLETED   7   12 
Adverse Event                1                0 
Lost to Follow-up                0                1 
Withdrawal by Subject                3                2 
Death                0                3 
Non-compliant                0                4 
Did not meet eligibility requirement                2                1 
Other                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Valacyclovir four 500 mg tablets 3 times a day for 90 days
Placebo four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
Total Total of all reporting groups

Baseline Measures
   Valacyclovir   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   47   87 
Age 
[Units: Years]
Mean (Inter-Quartile Range)
 53.5 
 (14 to 77) 
 56 
 (26 to 83) 
 55 
 (14 to 83) 
Age, Customized 
[Units: Participants]
     
12-18 years   2   0   2 
19-40 years   7   5   12 
41-60 years   18   22   40 
61 years or older   13   20   33 
Gender 
[Units: Participants]
     
Female   20   20   40 
Male   20   27   47 
Region of Enrollment 
[Units: Participants]
     
United States   8   9   17 
Canada   6   4   10 
United Kingdom   0   3   3 
Sweden   26   31   57 


  Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Effect of Study Medication on Quality of Life Measurements.   [ Time Frame: Day 0 and 90, Day 0 and Month 6 and Day 0 and Month 12 ]

3.  Secondary:   Effect of Antiviral Therapy on Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) in Cerebral Spinal Fluid (CSF)   [ Time Frame: Day 0 and Day 90. ]

4.  Secondary:   Median Number of Reported AEs Describing Safety and Tolerance of Valacyclovir (VACV), Evaluated by the Number Adverse Events, Administered at a Dose of 2.0 Grams Given Orally 3 Times a Day for 90 Days.   [ Time Frame: 6 months ]

5.  Secondary:   Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Mattis Dementia Rating Scale (MDRS)   [ Time Frame: 90 days, 6 and 12 months ]

6.  Secondary:   Survival With no or Mild Neuropsychological Impairment at 90 Days, and at 6 and 12 Months, as Measured by the Mini-Mental Status Examination (MMSE).   [ Time Frame: 90 days, 6 and 12 months ]

7.  Secondary:   Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Glasgow Coma Scale (GCS).   [ Time Frame: 90 days, 6 and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Penny Jester
Organization: University of Alabama at Birmingham
phone: (877) 975-7280
e-mail: pjester@peds.uab.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00031486     History of Changes
Obsolete Identifiers: NCT00001124
Other Study ID Numbers: 98-022
CASG 204
N01AI30025C
First Submitted: March 6, 2002
First Posted: March 7, 2002
Results First Submitted: March 15, 2012
Results First Posted: June 12, 2012
Last Update Posted: June 12, 2012