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 at least than or equal to 28 days of age as evidenced by infections limited to the skin, eye and mouth with normal CNS and treated with intravenous acyclovir therapy.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants enrolled while on 2 weeks of IV acyclovir therapy who have positive CSF HSV PCR results within 48 hours prior to IV therapy completion, are not randomized.

Reporting Groups

	Description
Placebo	Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
Acyclovir	Oral suspension 300 mg/m^2/dose TID for 6 months.

Participant Flow:   Overall Study

	Placebo	Acyclovir
STARTED	14	15
COMPLETED	4	8
NOT COMPLETED	10	7
Lost to Follow-up	0	1
Non-compliant	1	1
Re-activation of Disease	2	1
Disruption of blinded study drug supply	7	4

Reporting Groups

	Description
Placebo	Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
Acyclovir	Oral suspension 300 mg/m^2/dose TID for 6 months.

Baseline Measures

	Placebo	Acyclovir	Total
Number of Participants   [units: participants]	14	15	29
Age, Customized   [units: days] Median ( Full Range )	15     ( 5 to 55 )	15     ( 2 to 35 )	15     ( 2 to 55 )
Age, Customized   [units: participants]
< = 28 days	14	15	29
Between 29 days and 65 years	0	0	0
>=65 years	0	0	0
Gender   [units: participants]
Female	6	5	11
Male	8	10	18
Region of Enrollment   [units: participants]
United States	14	14	28
Canada	0	1	1

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 a Bayley's Neuro-developmental Assessment.(Mental Scores)   [ Time Frame: At 12 months of life. ]

3.  Secondary:

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

4.  Secondary:

Two or Fewer Episodes of Cutaneous Recurrence of HSV Disease Post-randomization During the Initial 12 Months of Life.   [ Time Frame: post randomization - 12 months ]