Phase 1 N=7 Other

Valacyclovir in Neonatal Herpes Simplex Virus Disease

Neonatal Herpes Simplex Infection

Bottom Line

View on ClinicalTrials.gov: NCT04448392 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Area Under the Curve Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours — 28.8 mgxh/l

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Valacyclovir (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours	28.8	—
PRIMARY Creatinine Clearance Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours	3.1	—
PRIMARY Half-life Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours	2.7	—
SECONDARY Area Under the Curve Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours	70.1	—
SECONDARY Half-life Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours	2.5	—
SECONDARY Creatinine Clearance Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours	1.1	—
SECONDARY Comparison of the Area Under the Curve of 20 mg/kg IV Acyclovir to the Area Under the Curve of 20 mg/kg PO Valacyclovir	28.8; 74	—

Summary

This is an open-label, single center, pharmacokinetic (PK) study to assess valacyclovir pharmacokinetics and pharmacodynamics in neonates and compare to the pharmacokinetics and pharmacodynamics of the standard of care treatment dose of intravenous acyclovir. 6 (up to 10 infants) with virologically confirmed neonatal herpes simplex virus (HSV) disease who meet all inclusion/exclusion criteria will be enrolled in the study. Study duration is 5 years. Primary objective is to define the pharmacokinetics of valacyclovir and assess its safety in neonates 2-12 weeks of age who are ≥ 34 weeks gestation.

Eligibility Criteria

Inclusion Criteria

Signed informed consent from parent(s) or legal guardian(s)
Confirmation of HSV infection from surface culture/PCR, skin lesion culture/PCR, blood PCR, or CSF PCR (performed at UAB Virology lab)
≥34 weeks gestational age at birth
Weight at study enrollment is ≥ 2000 grams
Receiving intravenous acyclovir, prescribed by the patient's physician for ≤ 14 days
≤ 42 days of age at initiation of parenteral acyclovir
Creatinine ≤ 1.2

Exclusion Criteria

Imminent demise
Current receipt of other investigational drugs
Major congenital anomaly that in the site investigator's opinion may impact drug metabolism or the patient's volume of distribution
Creatinine of > 1.2 prior to initiation of valacyclovir
Evidence of immunosuppression (HIV infected, immune deficiencies, etc.)
Any condition that, in the opinion of the investigator, would place the subject at an unacceptable injury risk or that may interfere with successful study completion
> 42 days of age at initiation of parenteral acyclovir
Concern for parental/guardian compliance

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04448392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.