Valacyclovir in Neonatal Herpes Simplex Virus Disease

Completed · Phase 1

Conditions studied: Neonatal Herpes Simplex Infection

In brief

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.

Key facts

Study ID

NCT04448392

Run by

University of Alabama at Birmingham

People needed

7

Starts

2021-07-01

Expected to finish

2024-07-24

Last updated by the study team

2025-06-24

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama - Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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