NCT00004644

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 0 Years – 28 Days
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Herpes Simplex

Interventions

Type	Name	Description
DRUG	acyclovir

Timeline

• Start date: 1995-02-01
• First posted: 2000-02-25
• Last updated: 2005-06-24