Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Center for Research Resources (NCRR)
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)