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

Purpose

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	Intervention	Phase
Herpes Simplex	Drug: acyclovir	Phase III

MedlinePlus related topics:

Herpes Simplex

ChemIDplus related topics:

Acyclovir Acyclovir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date:

August 1992

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

Ages Eligible for Study:	up to 29 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004757

Sponsors and Collaborators

National Center for Research Resources (NCRR)

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Study Chair:	Richard J. Whitley	National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Study ID Numbers:	199/11687, NIAID-558609
First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004757
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

herpes simplex virus infection

herpesvirus infection

immunologic disorders and infectious disorders

rare disease

viral infection

Study placed in the following topic categories:

Virus Diseases

Herpes Simplex

Skin Diseases, Infectious

Acyclovir

Skin Diseases

Neonatal herpes

Rare Diseases

DNA Virus Infections

Herpesviridae Infections

Additional relevant MeSH terms:

Skin Diseases, Viral

Anti-Infective Agents

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004757