Pharmacokinetics of Valacyclovir Oral Solution in Children

Pharmacokinetics of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of Varicella Zoster Virus (VZV) and Herpes Simplex Virus (HSV) Infections in Children, Phase II (VALID II)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04081480

Acronym

VALID2

Enrollment

Registered

2019-09-09

Start date

2019-12-10

Completion date

2021-05-12

Last updated

2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex Virus Infection, Varicella Zoster Virus Infection

Brief summary

Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing. The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir. Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.

Interventions

DRUGValacyclovir

PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Intervention is pharmacokinetic (PK) curve collection in children, two age groups

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

Inclusion criteria

* Subject is in the age of 2-12 years. * Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution. * Subject is managed with a central venous catheter (CVC/Port-a-Cath). * Subject's parents have signed the Informed Consent Form prior to screening evaluations. * Subject is willing to participate after study procedures are explained in comprehensible language for the child.

Exclusion criteria

* Severe anemia (\<6.0 mmol/L). * Full dose has not been taken.

Design outcomes

Primary

Measure	Time frame	Description
Area under the curve	12 hours	Acyclovir area under the curve (12h)
Cmax	12 hours	Maximum concentration of aciclovir
Tmax	12 hours	Time to reach maximum concentration of aciclovir

Secondary

Measure	Time frame	Description
Number of adverse events	1 day	Number of adverse events

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026