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

NCT00004757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • Herpes Simplex

Interventions

DRUG

acyclovir

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Richard J. Whitley · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
0 Years
Max Age
29 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1992-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004757 on ClinicalTrials.gov