Neonatal Phase 1 Valacyclovir Study

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Description

A Phase 1 study that will determine the valacyclovir dose that results in a systemic acyclovir exposure comparable to 10 mg/kg of parenterally administered acyclovir, which is an AUC0-12 of 24,000 ngxhr/mL to 48,000 ngxhr/mL. Neonates at risk of acquiring neonatal HSV will be enrolled in one of 2 cohorts. Cohort 1 will be comprised of eight subjects who will receive an initial dose of 10ml/kg of oral valacyclovir. Samples for PK assessments will be obtained to assess the exposure concentration. If the safety profile and the drug exposure concentrations in Cohort 1 are acceptable, eight new subjects will be enrolled in Cohort 2. The dose that these subjects will receive will be predicated upon the pharmacokinetic data from Cohort 1.

Targeted Conditions

Study Overview

Start Date
September 23, 2022
Completion Date
November 29, 2024
Enrollment
16
Date Posted
July 21, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Children's of Alabama Child Health Research Unit (CHRU)
Birmingham, Alabama 35233-0011, United States

University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases
Louisville, Kentucky 40202, United States

M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota 55454, United States

Washington University in St. Louis
Saint Louis, Missouri 63110-1010, United States

University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases
Omaha, Nebraska 68114-4108, United States

University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York 14642-0001, United States

Atrium Health ID Consultants & Infusion Care Specialists
Charlotte, North Carolina 28207, United States

Eligibility

Maximum Age (years)
0.005
Eligibility Criteria
Inclusion Criteria:

Signed informed consent from parent(s) or legal guardian(s)
Maternal history of genital HSV infection
Maternal receipt of oral acyclovir, valacyclovir, or famciclovir suppressive therapy for = 7 days prior to delivery
Gestational age = 38 weeks at birth
= 2 days of age at study enrollment
Weight at study enrollment = 2,000 grams

Exclusion Criteria:

Evidence of neonatal HSV infection
Evidence of sepsis
Known renal anomalies or dysfunction
Maternal genital lesions suspicious for HSV at the time of delivery
Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry)
Current receipt in the neonate of acyclovir, ganciclovir, famciclovir, or any investigational drugs

Study Contact Info

Study Contact Name
David W. Kimberlin
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed Description
A Phase 1, open label multicenter trial to assess the safety and pharmacokinetics (PKs) of oral valacyclovir in neonates who are at risk of acquiring neonatal herpes simplex virus disease. This study will determine the valacyclovir dose that results in a systemic acyclovir exposure comparable to 10 mg/kg of parenterally administered acyclovir, which is an AUC0-12 of 24,000 ngxhr/mL to 48,000 ngxhr/mL. Neonates whose mothers have a history of genital HSV infection and received oral valacyclovir in the last several weeks of pregnancy, as per the recommendations of the American College of Obstetrics and Gynecology (ACOG) (9), will be eligible for enrollment. Cohort 1 will be comprised of eight subjects. Following informed consent, each subject will receive 10 mg/kg of oral valacyclovir, and may start taking oral valacyclovir while still in the birth hospital, with subsequent dosing at home, or may start taking oral valacyclovir following discharge from the birth hospital. If the safety profile and the drug exposure concentrations in Cohort 1 are acceptable, eight new subjects will be enrolled in Cohort 2. The dose that these subjects will receive will be predicated upon the pharmacokinetic data from Cohort 1. The primary study objective is to establish the dose of valacyclovir in neonates that reliably achieves systemic acyclovir exposures comparable to 10 mg/kg of parenterally administered acyclovir. The secondary study objectives are: 1) to define the pharmacokinetic profile of acyclovir in neonates receiving oral valacyclovir and 2) to assess and describe the safety profile of valacyclovir among treated neonates.
NCTid (if applicable)
NCT05468619