A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.

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Key information

Conditions

Herpes Simplex DNA Virus Infections Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Santiago, Región Metro de Santiago, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who have a current herpes virus infection.
Have neonatally acquired herpes at risk of potential recurrence.
Immunocompromised or cancer patients at risk for development of a herpes virus infection.

Exclusion criteria

Hypersensitivity to antiherpetic medications.
Impaired hepatic or renal function.
Show presence of other serious or unstable underlying disease.

Treatment and study plan

Valaciclovir

Drug

Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.

Primary outcomes

Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose.

Time frame: 0.5, 1, 2, 4 and 6 hours

Secondary outcomes

Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.

Time frame: Up to Day 5

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2007
First posted: Feb 28, 2006
Registry last updated: Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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