EICHOR
● Completed
Neonatal Phase 1 Valacyclovir Study
Condition: Herpes Simplex · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
About this study
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.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (12)
| 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 | — |
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Source record: clinicaltrials.gov/study/NCT05468619