Valacyclovir in Neonatal Herpes Simplex Virus Disease

• Status: Recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single center, pharmacokinetic (PK) study to assess valacyclovir pharmacokinetics and pharmacodynamics in neonates and compare to the pharmacokinetics and pharmacodynamics of the standard of care treatment dose of intravenous acyclovir. 6 (up to 10 infants) with virologically confirmed neonatal herpes simplex virus (HSV) disease who meet all inclusion/exclusion criteria will be enrolled in the study. Study duration is 5 years. Primary objective is to define the pharmacokinetics of valacyclovir and assess its safety in neonates 2-12 weeks of age who are ≥ 34 weeks gestation.

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

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Valacyclovir

Criteria

Inclusion Criteria:

• Signed informed consent from parent(s) or legal guardian(s)

• Confirmation of HSV infection from surface culture/PCR, skin lesion culture/PCR, blood PCR, or CSF PCR (performed at UAB Virology lab)

• ≥34 weeks gestational age at birth

• Weight at study enrollment is ≥ 2000 grams

• Receiving intravenous acyclovir, prescribed by the patient's physician for ≤ 14 days

• ≤ 42 days of age at initiation of parenteral acyclovir

• Creatinine ≤ 1.2

Exclusion Criteria:

• Imminent demise

• Current receipt of other investigational drugs

• Major congenital anomaly that in the site investigator's opinion may impact drug metabolism or the patient's volume of distribution

• Creatinine of > 1.2 prior to initiation of valacyclovir

• Evidence of immunosuppression (HIV infected, immune deficiencies, etc.)

• Any condition that, in the opinion of the investigator, would place the subject at an unacceptable injury risk or that may interfere with successful study completion

• > 42 days of age at initiation of parenteral acyclovir

• Concern for parental/guardian compliance