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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00031486 |
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.
Condition | Intervention | Phase |
---|---|---|
Encephalitis |
Drug: Placebo Drug: Valacyclovir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 120 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Valacyclovir
4 tablets (500 mg) 3X per day for 90 days
|
2: Placebo Comparator |
Drug: Placebo
Placebo
|
Herpes simplex encephalitis (HSE) remains the most common cause of sporadic fatal encephalitis in the world. This study is a phase III, double-blind, placebo controlled study of long term therapy with valacyclovir as a treatment of herpes encephalitis. The primary objective of this study is to assess the impact of valacyclovir (VACV) therapy (following standard intravenous Acyclovir therapy) on neuropsychological impairment at one year post therapy, based on the cumulative scores of the Mattis Dementia Rating Scale (MDRS). The secondary objectives of the study are to: assess the effect of therapy on neuropsychological impairment at various time points; assess the effect of therapy on quality of life, based on the SF-36 Quality of Life Assessment; measure the effect of therapy on Herpes Simplex Virus (HSV) DNA in the cerebral spinal fluid (CSF); and assess the safety and tolerability of long term VACV therapy in patients with HSE. The tertiary objective of the study is to determine the frequency of symptomatic relapse/recurrence of HSE. Study participants will include 120 males and females, 12 years of age and older, diagnosed with HSE; laboratory confirmed CSF positive for HSV DNA by polymerase chain reaction (PCR). Consenting study participants will be randomized (1:1) to either valacyclovir (active drug), 500 mg tablets, four tablets three times daily for 90 days or placebo (identical to active drug in appearance), 500 mg tablets, four tablets three times daily for 90 days. The primary endpoints of the study are to assess the impact of valacyclovir therapy [following standard intravenous Acyclovir (ACV) therapy] on neuropsychological impairment at one year post therapy and survival with no or mild neuropsychological impairment at 12 months after initiation of study medication, as measured by the MDRS. The secondary endpoints include: survival with no or mild neuropsychological impairment at 90 days and at 6, 12 and 24 months, as measured by the MDRS, the Mini-Mental Status Examination (MMSE), and the Glasgow Coma Scale; effect of study medication on quality of life measurements; effect of antiviral therapy on HSV DNA in CSF (measured quantitatively by PCR at Day 0 and Day 90); and safety and tolerance of VACV administered at a dose of 2.0 grams given orally three times a day for 90 days. Tertiary endpoints include: frequency of symptomatic relapse/recurrence of HSE; survival with no or mild neuropsychological impairment at various time points, based on analysis of a disease-specific subset of questions from the test panel that measure frontal and/or temporal lobe dysfunction; survival with no or mild neuropsychological impairment at various time points assessed on an individual-subject basis using age, education, and IQ estimate, matched normative data for each subject as measured by the MDRS, MMSE, and tests of frontal/temporal lobe function; effect of antiviral therapy on HSV DNA in serum (measured quantitatively by PCR at clinical presentation, Day 0, and Day 90); and effect of antiviral therapy on HSV antibody in CSF as measured at clinical presentation, Day 0, and Day 90.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with encephalopathy consistent with HSE whose CSF (or brain biopsy sample) is positive for HSV DNA by PCR.
NOTE: The purpose of this study is to assess patients with herpes simplex encephalitis, which is usually caused by HSV-1 and occasionally caused by HSV-2. A syndrome of HSV aseptic meningitis may also be encountered and is most often caused by HSV-2. HSV aseptic meningitis will result in a positive CSF PCR for HSV DNA. Investigators should not enroll subjects whose clinical and radiographic findings are suggestive of HSV meningitis without encephalitis. Investigators with questions about subject eligibility should contact one of the Protocol Chairs.
Exclusion Criteria:
Contact: Ilet Dale | (205) 934-5316 | idale@peds.uab.edu |
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 98-022, CASG 204 |
Study First Received: | March 6, 2002 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00031486 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
Encephalitis, Herpes Simplex, Valacyclovir |
Valacyclovir Virus Diseases Herpes Simplex Encephalitis, Herpes Simplex Central Nervous System Infections Herpes simplex encephalitis |
Central Nervous System Diseases DNA Virus Infections Brain Diseases Encephalitis Herpesviridae Infections |
Encephalitis, Viral Anti-Infective Agents Therapeutic Uses Nervous System Diseases |
Central Nervous System Viral Diseases Antiviral Agents Pharmacologic Actions |