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

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ClinicalTrials.gov Identifier: NCT00004644
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Office of Rare Diseases (ORD)

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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Drug: acyclovir Phase 1 Phase 2

Detailed Description:


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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Primary Purpose: Treatment
Study Start Date : February 1995

Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004644

Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Richard J. Whitley
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ClinicalTrials.gov Identifier: NCT00004644    
Other Study ID Numbers: 199/11690
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1999
Keywords provided by Office of Rare Diseases (ORD):
herpes simplex virus infection
herpesvirus infection
immunologic disorders and infectious disorders
rare disease
viral infection
Additional relevant MeSH terms:
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Herpes Simplex
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents