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Assessment of oral acyclovir in neonates with HSV involving the CNS
This study is currently recruiting patients.
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) |
Purpose
The purpose of this study is to test whether long-term treatment (6 months) with oral acyclovir improves the outcome for infants with HSV infection of the brain or spinal cord (central nervous system, or CNS disease).
Condition | Treatment or Intervention | Phase |
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Herpes Simplex |
Drug: Acyclovir Oral Suspension Drug: Zovirax Oral Acyclovir (ACV) Suspension |
Phase III |
MedlinePlus related topics: Herpes Simplex
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control, Parallel Assignment
Official Title: A Placebo-controlled Phase III Evaluation of Suppressive Therapy with Oral Acyclovir Suspension Following Neonatal Herpes Simplex Virus Infections Involving the Central Nervous System
Expected Total Enrollment: 66
Study start: August 1997
Infants diagnosed with HSV disease involving the central nervous system (CNS) are routinely treated with intravenous (IV) acyclovir for 21 days. Infants enrolled in this study will have a spinal tap (a procedure which removes fluid from the spinal column), performed before the end of the IV treatment, to test for HSV improvement. If there is improvement (no evidence of HSV), patients are selected to receive oral acyclovir therapy or placebo for 6 months. If there is evidence of HSV, patients will qualify for a Pilot Sub-study and receive additional IV acyclovir.
Eligibility
Ages Eligible for Study: up to 24 Months, Genders Eligible for Study: Both
Criteria
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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