Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin lesions and improves neurologic outcome in neonates with localized herpes simplex virus type 2 infection when administered for 6 months in a placebo-controlled study.

II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic morbidity.

III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory abnormalities associated with long-term oral ACV therapy in infants and young children.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Acyclovir

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Virologically confirmed herpes simplex virus type 2 (HSV-2) with skin lesions localized to the skin, eyes, and mouth

• No central nervous system or disseminated disease Normal cerebrospinal fluid WBC less than 20 Protein less than 90 mg/dL

• Normal brain computerized tomography or magnetic resonance imaging (MRI) MRI if feasible

• No HSV-1

--Patient Characteristics--

• Age: Under 29 days

• Renal: Creatinine no greater than 1.5 mg/dL

• Other: Birth weight at least 1200 g

• Gestational age greater than 32 weeks

• No breast feeding if mother on acyclovir