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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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004757
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: January 1998
History of Changes

February 24, 2000
June 23, 2005
August 1992
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Complete list of historical versions of study NCT00004757 on ClinicalTrials.gov Archive Site
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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
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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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Herpes Simplex
Drug: acyclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
up to 29 Days
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004757
199/11687, NIAID-558609
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National Center for Research Resources (NCRR)
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Richard J. Whitley National Institute of Allergy and Infectious Diseases (NIAID)
Office of Rare Diseases (ORD)
January 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP