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

Completed · Phase 1

Conditions studied: Herpes Simplex

In brief

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.

Key facts

Study ID

NCT00297206

Run by

GlaxoSmithKline

People needed

36

Starts

2003-01-25

Expected to finish

2007-02-28

Last updated by the study team

2017-09-11

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.