NCT04448392

Valacyclovir in Neonatal Herpes Simplex Virus Disease

Completed Phase 1 Results posted Last updated 24 June 2025

What this trial tests

Phase 1 trial testing Valacyclovir in Neonatal Herpes Simplex Infection in 7 participants. Completed in 24 July 2024.

Timeline

1 July 2021

Primary endpoint
24 July 2024

24 July 2024

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	7
Start date	1 July 2021
Primary completion	24 July 2024
Estimated completion	24 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Valacyclovir — full drug profile →

Conditions studied

• Neonatal Herpes Simplex Infection — all drugs for Neonatal Herpes Simplex Infection →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 2 Weeks to 12 Weeks, any sex, with Neonatal Herpes Simplex Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Blood will be collected to determine the drug concentration of acyclovir, the metabolite of valacyclovir and will include AUC.

Group	Value	95% CI
Neonatal HSV Disease Requiring Suppressive Therapy	28.8	± 16.8

Creatinine Clearance Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours Primary · Between Day 2 and Day 7 of valacyclovir administration: 0, 1-2, 3-5 hours.

Blood will be collected to determine the drug concentration of acyclovir, the metabolite of valacyclovir and will include CL/F.

Group	Value	95% CI
Neonatal HSV Disease Requiring Suppressive Therapy	3.1	± 1.8

Half-life Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours Primary · Between Day 2 and Day 7 of valacyclovir administration: 0, 1-2, 3-5 hours.

Blood will be collected to determine the drug concentration of acyclovir, the metabolite of valacyclovir and will include T1/2.

Group	Value	95% CI
Neonatal HSV Disease Requiring Suppressive Therapy	2.7	± 1.2

Area Under the Curve Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours Secondary · One PK level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 PK levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion)

This study will determine the blood concentrations of acyclovir flowing valacyclovir administration. The goal is to define the valacyclovir dose which will allow a switch from IV to PO medication. In so doing, the potential duration of hospitalization can be decreased. To achieve this end, blood is collected to determine AUC.

Group	Value	95% CI
Neonatal HSV Disease Requiring Suppressive Therapy	70.1	± 41

Half-life Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours Secondary · One PK level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 PK levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion)

This study will determine the blood concentrations of acyclovir flowing valacyclovir administration. The goal is to define the valacyclovir dose which will allow a switch from IV to PO medication. In so doing, the potential duration of hospitalization can be decreased. To achieve this end, blood is collected to determine T1/2 of drug.

Group	Value	95% CI
Neonatal HSV Disease Requiring Suppressive Therapy	2.5	± 1.3

Creatinine Clearance Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours Secondary · One PK level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 PK levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion)

This study will determine the blood concentrations of acyclovir flowing valacyclovir administration. The goal is to define the valacyclovir dose which will allow a switch from IV to PO medication. In so doing, the potential duration of hospitalization can be decreased. To achieve this end, blood is collected to determine creatinine clearance of drug.

Group	Value	95% CI
Neonatal HSV Disease Requiring Suppressive Therapy	1.1	± 0.4

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 Secondary · Random PK levels on days 1-7 of acyclovir administration, PK levels obtained on one day between day 8-14 at specified time intervals, and PK levels obtained one day while on valacyclovir (see outcome 1 and outcome 3 for time intervals)

To determine if the concentration of the active metabolite acyclovir after administration of acyclovir and valacyclovir at specified time intervals produces the same area under the curve

PO valacyclovir AUC

Group	Value	95% CI
Neonatal HSV Disease Requiring Suppressive Therapy	28.8	± 16.8

IV acyclovir AUC (linear adjustment)

Group	Value	95% CI
Neonatal HSV Disease Requiring Suppressive Therapy	74	± 41.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.