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

Primary Purpose

Herpes Simplex

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

acyclovir

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring herpes simplex virus infection, herpesvirus infection, immunologic disorders and infectious disorders, rare disease, viral infection

Eligibility Criteria

0 Years - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004644

First Posted

February 24, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00004644

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 1999

Overall Recruitment Status

Completed

Study Start Date

February 1995 (undefined)

Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Simplex

Keywords

herpes simplex virus infection, herpesvirus infection, immunologic disorders and infectious disorders, rare disease, viral infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Enrollment

25 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

acyclovir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard J. Whitley

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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