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

Herpes Simplex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297206
• Other study ID #: HS210914
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2006
• Last updated: September 8, 2017
• Start date: January 25, 2003
• Est. completion date: February 28, 2007

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 28, 2007
• Est. primary completion date: February 28, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Drug:
• Valaciclovir
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.

Locations

Country	Name	City	State
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
South Africa	GSK Investigational Site	Brits
South Africa	GSK Investigational Site	George
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Chile,  South Africa, 

References & Publications (2)

Bradley J, Scholtz F, Brennan C, Zhao H, Weller S. Pharmacokinetics and safety of single-dose valacyclovir oral suspension in infants and children with current or potential herpesvirus infection. Poster presentation, 45th Annual Meeting Infectious Disease

Kimberlin DW, Jacobs RF, Weller S, van der Walt JS, Heitman CK, Man CY, Bradley JS. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age. Clin Infect Dis. 2010 Jan 15;50(2):221-8. doi: 10.1086/649212. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		0.5, 1, 2, 4 and 6 hours
Secondary	Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.		Up to Day 5

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study HS210914 can be found on the GSK Clinical Study Register.