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

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

This study has been completed.

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

ChemIDplus related topics:

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

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

Herpes Simplex

Skin Diseases, Infectious

Acyclovir

Neonatal herpes

Rare Diseases

DNA Virus Infections

Herpesviridae Infections

Additional relevant MeSH terms:

Skin Diseases, Viral

Virus Diseases

Anti-Infective Agents

Skin Diseases

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008