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Neonatal Phase 1 Valacyclovir Study
Neonatal Phase 1 Valacyclovir Study

NCT05468619

CompletedPhase 1

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

Conditions: Herpes Simplex

Interventions: Valacyclovir

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 1 Day to 2 Days

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (12)
  • Birmingham, Alabama, United States
  • Atlanta, Georgia, United States
  • Louisville, Kentucky, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Queens, New York, United States
  • Rochester, New York, United States
  • Syracuse, New York, United States
  • Charlotte, North Carolina, United States
  • Columbus, Ohio, United States
  • Milwaukee, Wisconsin, United States