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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004757
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Office of Rare Diseases (ORD)

Brief 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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Drug: acyclovir Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1992

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 29 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004757

Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Richard J. Whitley National Institute of Allergy and Infectious Diseases (NIAID)

Layout table for additonal information Identifier: NCT00004757     History of Changes
Other Study ID Numbers: 199/11687
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1998
Keywords provided by Office of Rare Diseases (ORD):
herpes simplex virus infection
herpesvirus infection
immunologic disorders and infectious disorders
rare disease
viral infection
Additional relevant MeSH terms:
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Herpes Simplex
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents