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

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex

Intervention: acyclovir (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
Richard J. Whitley, Study Chair


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.

Clinical Details

Study design: Primary Purpose: Treatment

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.


Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.



- -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

Locations and Contacts

Additional Information

Starting date: February 1995
Last updated: June 23, 2005

Page last updated: August 23, 2015

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