Neonatal Phase 1 Valacyclovir Study
Completed · Phase 1
Conditions studied: Herpes Simplex
In brief
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.
Key facts
- Study ID
- NCT05468619
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 17
- Starts
- 2023-08-07
- Expected to finish
- 2025-07-15
- Last updated by the study team
- 2026-07-23
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- For purposes of this study, the calendar day of birth is Day of Life 0
You may not qualify if…
- 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
Where it is running
- Children's of Alabama Child Health Research Unit (CHRU) — Birmingham, Alabama, United States
- Emory University School of Medicine — Atlanta, Georgia, United States
- University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases — Louisville, Kentucky, United States
- M Health Fairview Masonic Children's Hospital — Minneapolis, Minnesota, United States
- Washington University in St. Louis — St Louis, Missouri, United States
- Children's Nebraska — Omaha, Nebraska, United States
- Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease — Queens, New York, United States
- University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases — Rochester, New York, United States
- SUNY Upstate Medical University Hospital - Pediatrics — Syracuse, New York, United States
- Atrium Health ID Consultants & Infusion Care Specialists — Charlotte, North Carolina, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.