A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00297206

Purpose

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.

Condition	Intervention	Phase
Herpes Simplex	Drug: Valaciclovir	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.

Resource links provided by NLM:

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	36
Study Start Date:	January 2003

Intervention Details:

Other Name: Valaciclovir

Eligibility

Ages Eligible for Study:	1 Month to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297206

Locations

United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35233
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
GSK Investigational Site
San Diego, California, United States, 92123
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40503
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27705
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
United States, Texas
GSK Investigational Site
Galveston, Texas, United States, 77555-0653
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7580206
South Africa
GSK Investigational Site
Brits, South Africa, 2000
GSK Investigational Site
George, South Africa, 6529

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Publications:

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.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00297206 History of Changes
Other Study ID Numbers:	HS210914
Study First Received:	February 24, 2006
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

pharmacokinetics herpes varicella herpes labialis Epstein-Barr virus

Additional relevant MeSH terms:

Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012