Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth

Inclusion Criteria

• •PROTOCOL ENTRY CRITERIA:
• •-Disease Characteristics--
• •Infants diagnosed with herpes simplex virus infection limited to skin, eyes, and mouth; HSV-1 or HSV-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of skin lesions not required); normal CSF indices: WBC less than 22/mm3 and protein less than 115 mg/dL for term infants OR WBC less than 25/mm3 and protein less than 220 mg/dL for preterm infants; no evidence of CNS involvement by CT with contrast, MRI with gadolinium, or head ultrasound; no visceral dissemination (normal liver function tests, normal chest x-ray, etc.); negative CSF PCR result
• •Birth weight at least 800 grams
• •-Prior/Concurrent Therapy--
• •No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days; no prior prophylactic acyclovir for risk of herpes simplex virus infection
• •-Patient Characteristics--
• •Renal: Creatinine no greater than 1.5 mg/dL
• •Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage
• •Other: No infants known to be born to HIV-positive women