Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Neonates diagnosed with HSV-1 or HSV-2 <= 28 days of age with evidence of CNS HSV disease (with or without evidence of viral dissemination to other organs, such as the skin, liver, and lungs) then treated with intravenous acyclovir therapy. Subject has negative CSF PCR results within 48 hours prior to completion of intravenous acyclovir therapy.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects enrolled while on 2 - 3 weeks of IV acyclovir therapy who have positive cerebrospinal Fluid (CSF) herpes simplex virus (HSV) PCR results within 48 hours prior to IV therapy completion, are not randomized.

Reporting Groups

	Description
Acyclovir	Oral suspension 300 mg/m^2/dose TID for 6 months.
Placebo	Identical volume as acyclovir.

Participant Flow:   Overall Study

	Acyclovir	Placebo
STARTED	24	22
COMPLETED	15	8
NOT COMPLETED	9	14
Lost to Follow-up	0	1
Adverse Event	0	0
Withdrawal by Subject	1	1
Non-Compliant	1	1
Death	0	1
Reactivation of Disease	5	9
Disruption of blinded drug supply	2	0
Confirmed unevaluable	0	1

Reporting Groups

	Description
Acyclovir	Oral suspension 300 mg/m^2/dose TID for 6 months.
Placebo	Identical volume as acyclovir.

Baseline Measures

	Acyclovir	Placebo	Total
Number of Participants   [units: participants]	24	22	46
Age, Customized   [units: days] Median ( Full Range )	11     ( 1 to 42 )	15.5     ( 5 to 29 )	13     ( 1 to 42 )
Age, Customized   [units: participants]
<=28 days	24	22	46
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Gender   [units: participants]
Female	10	11	21
Male	14	11	25
Region of Enrollment   [units: participants]
United States	21	22	43
Canada	3	0	3

1.  Primary:

Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment (Motor Scores).   [ Time Frame: At 12 months of life. ]

2.  Primary:

Participants With Neurologic Impairment at 12 Months as Measured by Bayley's Neuro-developmental Assessment.(Mental Scores)   [ Time Frame: At 12 months of life. ]

3.  Secondary:

Number of Participants With Two or Fewer Episodes of Cutaneous Recurrence of Herpes Simplex Virus (HSV) Disease Post-randomization During the Initial 12 Months of Life.   [ Time Frame: post randomization - 12 months ]

4.  Secondary:

Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by PCR at Anytime During the Initial 12 Months of Life.   [ Time Frame: post randomization - 12 months ]