Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex
Intervention: acyclovir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Richard J. Whitley, Study Chair, Affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Detailed description:
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
participating institution.
All patients are treated with intravenous acyclovir for 14 days. Patients are then randomly
assigned to 1 of 2 treatment groups if the following criteria are met: no systemic disease
involvement, documented by negative cerebrospinal fluid exam, brain computerized tomography,
and magnetic resonance imaging; and entry criteria continue to be met.
Randomized treatment begins 8 hours after the final dose of intravenous acyclovir. One group
is treated with oral acyclovir, while the control group receives an oral placebo.
Treatment continues for 6 months in the absence of unacceptable toxicity, systemic disease,
and 2 or more recurrences of skin lesions. Patients are followed at 6 months, then yearly
for at least 4 years.
The study duration is estimated to be 4 years.
Eligibility
Minimum age: N/A.
Maximum age: 29 Days.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: August 1992
Last updated: June 23, 2005
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