Valacyclovir in Neonatal Herpes Simplex Virus Disease
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.
Conditions:
🦠 Neonatal Herpes Simplex Infection
🗓️ Study Start (Actual) 1 July 2021
🗓️ Primary Completion (Estimated) October 2025
✅ Study Completion (Estimated) November 2025
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 2 Weeks to 12 Weeks (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 June 2020
  • First Submitted that Met QC Criteria 24 June 2020
  • First Posted 25 June 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 September 2023
  • Last Update Posted 8 September 2023
  • Last Verified September 2023