Valacyclovir treatment for newborns at risk of herpes simplex virus
A Phase I Adaptive, Multiple Dose Pharmacokinetic and Safety Assessment of Valacyclovir in Infants at Risk of Acquiring Neonatal Herpes Simplex Virus Disease
This study is testing if an oral medication called valacyclovir is safe and effective for newborns at risk of getting herpes simplex virus disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 1 Day to 2 Days |
| Sex | All |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 12 sites (Birmingham, Alabama and 11 other locations) |
| Trial ID | NCT05468619 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial evaluates the safety and pharmacokinetics of oral valacyclovir in neonates who are at risk of acquiring neonatal herpes simplex virus disease. The study involves two cohorts of neonates, with the first cohort receiving an initial dose of 10 mg/kg of oral valacyclovir. The pharmacokinetic data from this cohort will inform the dosing for the second cohort. The primary goal is to establish a valacyclovir dose that achieves systemic acyclovir exposure comparable to standard parenteral treatment.
Who should consider this trial
Good fit: Ideal candidates include neonates with a maternal history of genital HSV infection who are at least 2 days old and weigh at least 2,000 grams.
Not a fit: Patients who are already infected with neonatal HSV or have other significant health issues, such as sepsis or renal dysfunction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more convenient oral treatment option for neonates at risk of herpes simplex virus infection.
How similar studies have performed: While this approach is novel in the context of neonates, previous studies have shown the efficacy of valacyclovir in treating herpes simplex virus in older populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: 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
Where this trial is running
Birmingham, Alabama and 11 other locations
- Children's of Alabama Child Health Research Unit (CHRU) — Birmingham, Alabama, United States (Recruiting)
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases — Louisville, Kentucky, United States (Recruiting)
- M Health Fairview Masonic Children's Hospital — Minneapolis, Minnesota, United States (Recruiting)
- Washington University in St. Louis — Saint Louis, Missouri, United States (Recruiting)
- Children's Nebraska — Omaha, Nebraska, United States (Recruiting)
- Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease — Queens, New York, United States (Not_yet_recruiting)
- University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases — Rochester, New York, United States (Recruiting)
- SUNY Upstate Medical University Hospital - Pediatrics — Syracuse, New York, United States (Recruiting)
- Atrium Health ID Consultants & Infusion Care Specialists — Charlotte, North Carolina, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: David W. Kimberlin
- Email: dkimberlin@uabmc.edu
- Phone: 12056382530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.