Neonatal Phase 1 Valacyclovir Study
Public ClinicalTrials.gov record NCT05468619. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT05468619
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- NIH
- Enrollment
- 17 participants
Conditions and interventions
Conditions
Interventions
- Valacyclovir Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Day to 2 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 6, 2023
- Primary completion
- Jun 7, 2025
- Completion
- Jul 14, 2025
- Last update posted
- Mar 31, 2026
2023 – 2025
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama Child Health Research Unit (CHRU) | Birmingham | Alabama | 35233-0011 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322-1014 | — |
| University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases | Louisville | Kentucky | 40202 | — |
| M Health Fairview Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110-1010 | — |
| Children's Nebraska | Omaha | Nebraska | 68114-4108 | — |
| Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease | Queens | New York | 11040 | — |
| University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases | Rochester | New York | 14642-0001 | — |
| SUNY Upstate Medical University Hospital - Pediatrics | Syracuse | New York | 13210-2342 | — |
| Atrium Health ID Consultants & Infusion Care Specialists | Charlotte | North Carolina | 28207 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205-2664 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3522 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05468619, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 31, 2026 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05468619 live on ClinicalTrials.gov.