Pharmacokinetics of Valacyclovir Oral Solution in Children (VALID2)

Radboud University Medical Center

Status: Terminated

Conditions: Herpes Simplex Virus Infection; Varicella Zoster Virus Infection

Treatments: Drug: Valacyclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT04081480

VALID2

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Valacyclovir oral solution

Other group

Description:

Valacyclovir oral solution as administered in standard of care. Dosage: 10 mg/kg BID for children weighing less than 40 kg and 500 mg BID for children weighing 40 kg or more.

Treatment:

Drug: Valacyclovir