Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031486
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2002-03-06
Brief Title:
Long Term Treatment of Herpes Simplex Encephalitis HSE With Valacyclovir
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 deoxyribonucleic acid 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 relapserecurrence 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 11 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 20 grams given orally three times a day for 90 days Each study participant will participate for approximately 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01AI30025C | None | None | None |
| CASG 204 | None | None | None |