COMPLETED

Neonatal Phase 1 Valacyclovir Study

Conditions

Herpes Simplex Disease Herpes Simplex Virus Neonatal Phase I Valacyclovir

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-07

Study Completion:2025-07-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05468619

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.

Ages Eligible for Study:1 Day to 2 Days

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Children's of Alabama Child Health Research Unit (CHRU)

Birmingham, Alabama, 35233-0011

United States

Emory University School of Medicine

Atlanta, Georgia, 30322-1014

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

St Louis, Missouri, 63110-1010

United States

Children's Nebraska

Omaha, Nebraska, 68114-4108

United States

Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease

Queens, New York, 11040

United States

University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases

Rochester, New York, 14642-0001

United States

SUNY Upstate Medical University Hospital - Pediatrics

Syracuse, New York, 13210-2342

United States

Atrium Health ID Consultants & Infusion Care Specialists

Charlotte, North Carolina, 28207

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205-2664

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3522

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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

Study Start Date2023-08-07

Study Completion Date2025-07-10

Study Record Updates

Study Start Date2023-08-07

Study Completion Date2025-07-10

Terms related to this study

Keywords Provided by Researchers

Disease
Herpes Simplex Virus
Neonatal
Phase I
Valacyclovir

Additional Relevant MeSH Terms

Herpes Simplex