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)
Information obtained from ClinicalTrials.gov on June 20, 2008
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
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.
Clinical Details
Study design: 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.
Eligibility
Minimum age: N/A.
Maximum age: 28 Days.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: February 1995
Last updated: June 23, 2005
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