At a glance
ClinicalIndex Comparison Record- ✓Documented HSV-1 or HSV-2 by viral culture from any site (skin, oropharynx, CSF, urine, etc.) if cutaneous lesions present; if no cutaneous lesions, either positive culture or positive CSF PCR required.
- ✓Evidence of CNS HSV disease: abnormal CSF indices (term: >22 WBCs/mm³ AND protein >115 mg/dL; preterm: >25 WBCs/mm³ AND protein >220 mg/dL), abnormal neuroimaging (CT with contrast, MRI with gadolinium, or head ultrasound), abnormal EEG, or positive CSF PCR for HSV DNA.
- ✓Negative CSF PCR result within 48 hours prior to completion of intravenous acyclovir therapy.
- ✓Age ≤28 days at initial presentation with CNS disease.
- ✕Grade 3 or grade 4 intraventricular hemorrhage (IVH) prior to enrollment.
- ✕Breastfeeding infants whose mothers are taking acyclovir, valacyclovir, or famciclovir for >120 hours (>5 days).
- ✕Infants born to women with known positive HIV status.
- ✕HSV infection limited to skin, eyes, or mouth (SEM); these patients are candidates for a separate CASG trial.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-Controlled Phase III Evaluation of Suppressive Therapy With Oral Acyclovir Suspension Following Neonatal Herpes Simplex Virus Infections Involving the Central Nervous System
In Brief
A Phase 3 clinical trial evaluating Acyclovir and Placebo for Herpes Simplex. Completed, enrolled 46 participants across 29 sites in 2 countries.
Detailed Summary
The purpose of this study is to test whether long term treatment with acyclovir given orally (by mouth) improves the outcome for infants with herpes simplex virus infection of the brain or spinal cord (known as the central nervous system \[CNS\]). Infants with herpes viral infection of the CNS that has or has not spread to other parts of the body will be enrolled in this study. All participants will receive treatment in a hospital for 21 days with acyclovir, given intravenously (by a needle inserted into a vein). Participants will then be divided into two groups: those with CNS disease that has or has not spread to the skin, and those whose viral infection has spread and involves the CNS. Both groups will be randomly assigned to receive either oral acyclovir or placebo (inactive substance) for 6 months. Infants in the US and Canada will participate for 5 years. A physical exam, hearing exam, eye exam, and an evaluation of the nervous system will be performed throughout the study.
Study Details
Timeline
Interventions
Oral banana flavored acyclovir suspension: 300 mg/m\^2/dose three times a day (TID), to be given at least 6 to 8 hours apart for 6 months. Dosage adjustments will be made monthly to compensate for increases in body surface area.
Oral banana flavored placebo suspension: to be given at least 6 to 8 hours apart for 6 months. Dosage adjustments will be made monthly to compensate for increases in body surface area.