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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	Related Studies

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

This study has been completed.
Information provided by Office of Rare Diseases (ORD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Brief Summary

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.

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.

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Herpes Simplex

Intervention ^†

Drug: acyclovir

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

February 1995

Completion Date

Eligibility 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

Gender

Both

Ages

up to 28 Days

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00004644

Organization ID

199/11690

Secondary IDs ^††

NIAID-17116

Study Sponsor ^†

National Center for Research Resources (NCRR)

Collaborators ^††

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators ^†

Study Chair:

Richard J. Whitley

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

March 1999

First Received Date ^†

February 24, 2000

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.