Overview

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