Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

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:	NCT00004644

Purpose

OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity and mortality in neonates with central nervous system or disseminated herpes simplex virus (HSV) infection. II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess resistance to antiviral medication. IV. Amplify disease classification for the purpose of predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate whether antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid (CSF) predict long-term neurologic outcome. VII. Evaluate whether specific antigens and antibodies in the CSF appear late after treatment and are indicative of insidious reactivation of virus in the brain.

Condition	Intervention	Phase
Herpes Simplex	Drug: acyclovir	Phase I Phase II

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Estimated Enrollment:	25
Study Start Date:	February 1995

Detailed Description:

PROTOCOL OUTLINE:

Neonates are treated with intravenous acyclovir for 21 days. Patients are followed at day 28, and at 6, 12, 24, 36, and 48 months.

Eligibility

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Herpes simplex virus infection that is disseminated or localized to the central nervous system Virologically confirmed by 1 of the following methods:

Tissue culture
Monoclonal antibody staining
Electron microscopy

--Prior/Concurrent Therapy--

No concurrent antiviral therapy

--Patient Characteristics--

Life expectancy: No imminent demise

Birth weight at least 1200 g Gestational age over 32 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004644

Sponsors and Collaborators

National Center for Research Resources (NCRR)

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Richard J. Whitley

More Information

No publications provided

Study ID Numbers:	199/11690, NIAID-17116
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004644 History of Changes
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

Rare Diseases
DNA Virus Infections
Antiviral Agents
Neonatal Herpes
Herpesviridae Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Virus Diseases
Herpes Simplex
Anti-Infective Agents
Skin Diseases, Infectious
Acyclovir

Skin Diseases
Therapeutic Uses
DNA Virus Infections
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009