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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-25

Study Completion Date

2007-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Herpes Simplex

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Subjects in the age group of 2 to less than 6 years will be included

Group Type EXPERIMENTAL

Valaciclovir

Intervention Type 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.

Cohort 2

Subjects in the age group of 1 to less than 2 years will be included

Group Type EXPERIMENTAL

Valaciclovir

Intervention Type 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.

Cohort 3

Subjects in the age group of 6 months to less than 1 year will be included

Group Type EXPERIMENTAL

Valaciclovir

Intervention Type 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.

Cohort 4

Subjects in the age group of 3 months to less than 6 months will be included

Group Type EXPERIMENTAL

Valaciclovir

Intervention Type 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.

Cohort 5

Subjects in the age group of 1 month to less than 3 months will be included

Group Type EXPERIMENTAL

Valaciclovir

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Jacksonville, Florida, United States

Site Status

GSK Investigational Site

Lexington, Kentucky, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

New Orleans, Louisiana, United States

Site Status

GSK Investigational Site

Durham, North Carolina, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Galveston, Texas, United States

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Brits, , South Africa

Site Status

GSK Investigational Site

George, , South Africa

Site Status

Countries

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United States Chile South Africa

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 20014952 (View on PubMed)

Study Documents

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