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



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

For Condition: Herpes Simplex
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /28 Days
Genders: Both
Protocol Entry 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
Total Enrollment: 25

Location and Contact Information:

Overall Study Official:
RichardWhitley,  Study Chair, 


Additional Information:
Study ID Numbers:
  199/11690;  NIAID-17116
Study Start Date: February 1995
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004644

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2. HERPEVAC Trial for Women

3. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System

4. Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth

5. A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients

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