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Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection

This study has been completed.
Information provided by Office of Rare Diseases (ORD)

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Descriptive Information Fields
Brief Title  Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
Official Title 
Brief Summary

OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity and mortality in neonates with central nervous system or disseminated herpes simplex virus (HSV) infection.

II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess resistance to antiviral medication. IV. Amplify disease classification for the purpose of predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate whether antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid (CSF) predict long-term neurologic outcome.

VII. Evaluate whether specific antigens and antibodies in the CSF appear late after treatment and are indicative of insidious reactivation of virus in the brain.

Detailed Description

PROTOCOL OUTLINE:

Neonates are treated with intravenous acyclovir for 21 days. Patients are followed at day 28, and at 6, 12, 24, 36, and 48 months.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Herpes Simplex
Intervention  Drug: acyclovir
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  25
Start Date  February 1995
Completion Date
Eligibility Criteria 

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Herpes simplex virus infection that is disseminated or localized to the central nervous system Virologically confirmed by 1 of the following methods:

  • Tissue culture
  • Monoclonal antibody staining
  • Electron microscopy

--Prior/Concurrent Therapy--

No concurrent antiviral therapy

--Patient Characteristics--

Life expectancy: No imminent demise

Birth weight at least 1200 g Gestational age over 32 weeks

Gender Both
Ages up to 28 Days
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00004644
Organization ID 199/11690
Secondary IDs †† NIAID-17116
Study Sponsor  National Center for Research Resources (NCRR)
Collaborators †† National Institute of Allergy and Infectious Diseases (NIAID)
Investigators 
Study Chair:     Richard J. Whitley        
Information Provided By Office of Rare Diseases (ORD)
Verification Date March 1999
First Received Date  February 24, 2000
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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