Trial Outcomes & Findings for Valacyclovir in Neonatal Herpes Simplex Virus Disease (NCT NCT04448392)
NCT ID: NCT04448392
Last Updated: 2025-06-24
Results Overview
Blood will be collected to determine the drug concentration of acyclovir, the metabolite of valacyclovir and will include AUC.
COMPLETED
PHASE1
7 participants
Between Day 2 and Day 7 of valacyclovir administration: 0, 1-2, 3-5 hours.
2025-06-24
Participant Flow
Participant milestones
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Valacyclovir in Neonatal Herpes Simplex Virus Disease
Baseline characteristics by cohort
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
n=7 Participants
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Age, Customized
0-20 days
|
4 Participants
n=5 Participants
|
|
Age, Customized
21-42 days
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Age at time of parental acyclovir profile (days)
|
30 days
n=5 Participants
|
|
Age at time of valacyclovir profile (days)
|
35 days
n=5 Participants
|
|
Interval between parental acyclovir and valacyclovir profile (days)
|
6 days
n=5 Participants
|
PRIMARY outcome
Timeframe: Between Day 2 and Day 7 of valacyclovir administration: 0, 1-2, 3-5 hours.Blood will be collected to determine the drug concentration of acyclovir, the metabolite of valacyclovir and will include AUC.
Outcome measures
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
n=7 Participants
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Area Under the Curve Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours
|
28.8 mgxh/l
Standard Deviation 16.8
|
PRIMARY outcome
Timeframe: Between Day 2 and Day 7 of valacyclovir administration: 0, 1-2, 3-5 hours.Blood will be collected to determine the drug concentration of acyclovir, the metabolite of valacyclovir and will include CL/F.
Outcome measures
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
n=7 Participants
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Creatinine Clearance Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours
|
3.1 L/h
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Between Day 2 and Day 7 of valacyclovir administration: 0, 1-2, 3-5 hours.Blood will be collected to determine the drug concentration of acyclovir, the metabolite of valacyclovir and will include T1/2.
Outcome measures
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
n=7 Participants
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Half-life Following Administration of Oral Valacyclovir Suspension 20 mg/kg Every 8 Hours
|
2.7 hrs.
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: One PK level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 PK levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion)This study will determine the blood concentrations of acyclovir flowing valacyclovir administration. The goal is to define the valacyclovir dose which will allow a switch from IV to PO medication. In so doing, the potential duration of hospitalization can be decreased. To achieve this end, blood is collected to determine AUC.
Outcome measures
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
n=7 Participants
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Area Under the Curve Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours
|
70.1 mgxh/L
Standard Deviation 41
|
SECONDARY outcome
Timeframe: One PK level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 PK levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion)This study will determine the blood concentrations of acyclovir flowing valacyclovir administration. The goal is to define the valacyclovir dose which will allow a switch from IV to PO medication. In so doing, the potential duration of hospitalization can be decreased. To achieve this end, blood is collected to determine T1/2 of drug.
Outcome measures
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
n=7 Participants
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Half-life Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours
|
2.5 hrs
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: One PK level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 PK levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion)This study will determine the blood concentrations of acyclovir flowing valacyclovir administration. The goal is to define the valacyclovir dose which will allow a switch from IV to PO medication. In so doing, the potential duration of hospitalization can be decreased. To achieve this end, blood is collected to determine creatinine clearance of drug.
Outcome measures
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
n=7 Participants
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Creatinine Clearance Following Administration of Parenteral Acyclovir 20 mg/kg Every 8 Hours
|
1.1 L/h
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Random PK levels on days 1-7 of acyclovir administration, PK levels obtained on one day between day 8-14 at specified time intervals, and PK levels obtained one day while on valacyclovir (see outcome 1 and outcome 3 for time intervals)To determine if the concentration of the active metabolite acyclovir after administration of acyclovir and valacyclovir at specified time intervals produces the same area under the curve
Outcome measures
| Measure |
Neonatal HSV Disease Requiring Suppressive Therapy
n=7 Participants
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
|
|---|---|
|
Comparison of the Area Under the Curve of 20 mg/kg IV Acyclovir to the Area Under the Curve of 20 mg/kg PO Valacyclovir
PO valacyclovir AUC
|
28.8 AUC- mgxh/l
Standard Deviation 16.8
|
|
Comparison of the Area Under the Curve of 20 mg/kg IV Acyclovir to the Area Under the Curve of 20 mg/kg PO Valacyclovir
IV acyclovir AUC (linear adjustment)
|
74 AUC- mgxh/l
Standard Deviation 41.0
|
Adverse Events
Neonatal HSV Disease Requiring Suppressive Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place