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NCT00004644 Clinical Trial

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

Herpes Simplex Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004644
Other study ID # 199/11690
Secondary ID NIAID-17116
Status Completed
Phase Phase 1/Phase 2
First received February 24, 2000
Last updated June 23, 2005
Start date February 1995

Study information
Verified date March 1999
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 28 Days
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• acyclovir

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) National Institute of Allergy and Infectious Diseases (NIAID)
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