At a glance
ClinicalIndex Comparison Record- ✓Isolation of HSV-1 or HSV-2 by viral culture from cutaneous lesions, conjunctivae, or oropharynx; detection at any of these sites is sufficient.
- ✓Normal CSF indices: <22 WBCs/mm³ and protein <115 mg/dL for term infants; <25 WBCs/mm³ and protein <220 mg/dL for preterm infants at both diagnosis and randomization.
- ✓No evidence of CNS HSV disease on CT with contrast, MRI with gadolinium, or head ultrasound.
- ✓Negative CSF HSV-PCR from specimens obtained within 72 hours of starting intravenous acyclovir and within 48 hours before completing intravenous acyclovir.
- ✕Grade 3 or 4 intraventricular hemorrhage (IVH) prior to enrollment.
- ✕CNS or disseminated HSV infection.
- ✕Creatinine >1.5 mg/dL at study enrollment.
- ✕Mothers known to be HIV-positive at time of evaluation for study inclusion.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-Controlled Phase III Evaluation of Suppressive Therapy With Oral Acyclovir Suspension Following Neonatal Herpes Simplex Virus Infections Limited to the Skin, Eye, and Mouth
In Brief
A Phase 3 clinical trial evaluating Acyclovir and Placebo for Herpes Simplex. Completed, enrolled 29 participants across 28 sites in 2 countries.
Detailed Summary
The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth (SEM). Study participants will include infants in the United States and Canada who have HSV disease of the skin, eyes, and mouth, with no central nervous system disease present. Initially, all subjects will be treated with acyclovir administered through IV access (through the vein) for 14 days while hospitalized. Participants will then be placed in one of two groups, acyclovir given by mouth or a placebo (substance with no medication present). The participant and the study site will not know to which group the subject is assigned. All children will be followed at 6, 12, 24, 36, 48, and 60 months of age. During the follow up visits, physicals, hearing assessments, eye assessments, and neurological assessments will be completed.
Study Details
Timeline
Interventions
Oral suspension 300 mg/m\^2/dose, 3 times per day (TID), for 6 months.
Placebo identical to oral acyclovir suspension in appearance and taste.