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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00297206
First Posted: February 28, 2006
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


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. [ Time Frame: 0.5, 1, 2, 4 and 6 hours ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Actual Study Start Date: January 25, 2003
Study Completion Date: February 28, 2007
Primary Completion Date: February 28, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects in the age group of 2 to less than 6 years will be included
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.
Experimental: Cohort 2
Subjects in the age group of 1 to less than 2 years will be included
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.
Experimental: Cohort 3
Subjects in the age group of 6 months to less than 1 year will be included
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.
Experimental: Cohort 4
Subjects in the age group of 3 months to less than 6 months will be included
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.
Experimental: Cohort 5
Subjects in the age group of 1 month to less than 3 months will be included
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 GlaxoSmithKline
  More Information

Additional Information:
Publications:
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

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: HS210914
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: HS210914
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: HS210914
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: HS210914
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: HS210914
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: HS210914
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: HS210914
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00297206     History of Changes
Other Study ID Numbers: HS210914
First Submitted: February 24, 2006
First Posted: February 28, 2006
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

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