Overview

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:

Participant gender:

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

Details

Lead Sponsor:

National Center for Research Resources (NCRR)

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Treatments:

Acyclovir