Neonatal Phase 1 Valacyclovir Study

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.

Conditions

Herpes Simplex

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A Phase I Adaptive, Multiple Dose Pharmacokinetic and Safety Assessment of Valacyclovir in Infants at Risk of Acquiring Neonatal Herpes Simplex Virus Disease

Neonatal Phase 1 Valacyclovir Study

Condition
Herpes Simplex
Intervention / Treatment

-

Contacts and Locations

Birmingham

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

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30322-1014

Louisville

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

Minneapolis

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

Saint Louis

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

Omaha

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

Queens

Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease, Queens, New York, United States, 11040

Rochester

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

Syracuse

SUNY Upstate Medical University Hospital - Pediatrics, Syracuse, New York, United States, 13210-2342

Charlotte

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Signed informed consent from parent(s) or legal guardian(s)
  • 2. Maternal history of genital HSV infection
  • 3. Maternal receipt of oral acyclovir, valacyclovir, or famciclovir suppressive therapy for = 7 days prior to delivery
  • 4. Gestational age = 38 weeks at birth
  • 5. = 2 days of age at study enrollment\*
  • 6. Weight at study enrollment = 2,000 grams
  • * For purposes of this study, the calendar day of birth is Day of Life 0
  • 1. Evidence of neonatal HSV infection
  • 2. Evidence of sepsis
  • 3. Known renal anomalies or dysfunction
  • 4. Maternal genital lesions suspicious for HSV at the time of delivery
  • 5. Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry)
  • 6. Current receipt in the neonate of acyclovir, ganciclovir, famciclovir, or any investigational drugs

Ages Eligible for Study

1 Day to 2 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Institute of Allergy and Infectious Diseases (NIAID),

Study Record Dates

2024-11-29