Valacyclovir in Neonatal Herpes Simplex Virus Disease

Conditions

• Neonatal Herpes Simplex Infection

Eligibility Criteria

Sex

ALL

Age

2 Weeks - 12 Weeks

Healthy Volunteers

Not accepted

Interventions

• Valacyclovir — DRUG
  Upon completion of standard of care acyclovir for treatment of neonatal HSV disease, valacyclovir oral suspension (per ASHP recipe), 20 mg/kg every 8 hours, to be given for 2 (up to 7) days

Study Details

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.

Key Dates

Start date

Jul 1, 2021

Status verified

Jun 2025

Primary completion

Jul 24, 2024

Completion

Jul 24, 2024

Study Design

Enrollment

7 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Other: Neonatal HSV disease requiring suppressive therapy
  All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.

Primary Outcome Measure

Area Under the Curve Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours [ Time Frame: Between Day 2 and Day 7 of valacyclovir administration: 0, 1-2, 3-5 hours. ]

Locations (1)

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