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

• Status: Completed
• Trial end date: 2007-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Acyclovir; Valacyclovir

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.