Status:
COMPLETED
Valacyclovir in Neonatal Herpes Simplex Virus Disease
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Neonatal Herpes Simplex Infection
Eligibility:
All Genders
2-12 years
Phase:
PHASE1
Brief 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 th...
Detailed Description
This is an open-label, single center, PK study to assess valacyclovir pharmacokinetics and pharmacodynamics in neonates and compare to the pharmacokinetics and pharmacodynamics of the standard of care...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04448392
Start Date
July 1 2021
End Date
July 24 2024
Last Update
June 24 2025
Active Locations (1)
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1
University of Alabama - Children's of Alabama
Birmingham, Alabama, United States, 35233-1711