Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System

NCT00006132 | Unknown Phase 3

• 2 other identifiers: 199/15325UAB-CASG-103
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 28

Brief Summary

OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection involving the central nervous system. II. Determine whether neurologic outcome is improved in these patients when treated with this regimen. III. Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients. IV. Determine the safety of this regimen in these patients.

Conditions

Herpes Simplex

Keywords

herpes simplex virus infection; herpes virus infection; immunologic disorders and infectious disorders; rare disease; viral infection

Interventions

acyclovir DRUG

Eligibility Criteria

• Age: 0 Years - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Infants diagnosed with herpes simplex virus infection involving the central nervous system with or without evidence of viral dissemination to other organs (i.e., skin, liver, or lungs) HSV-1 or HSV-2 isolated from cutaneous lesions from any site (skin, oropharynx, cerebrospinal fluid (CSF), urine, etc.) OR Must have positive CSF polymerase chain reaction (PCR) if no cutaneous skin lesions are present and viral cultures are negative No infection limited to skin, eyes, or mouth Evidence of CNS involvement includes one or more of the following: Abnormal CSF indices for term infants (WBC greater than 22/mm3 and protein greater than 115 mg/dL) Abnormal CSF indices for preterm infants (WBC greater than 25/mm3 and protein greater than 220 mg/dL) Abnormal neuroimaging study (CT with contrast, MRI with gadolinium, or head ultrasound) Disseminated disease is defined as one or more of the following: SGPT at least 2.5 times upper limit of normal Pneumonia/pneumonitis Necrotizing enterocolitis Disseminated intravascular coagulopathy * Birth weight at least 800 grams --Prior/Concurrent Therapy-- * No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days --Patient Characteristics-- * Renal: Creatinine no greater than 1.5 mg/dL * Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage * Other: No infants known to be born to HIV positive women

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• University of Alabama at Birmingham: collaborator

Study Sites (28)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

RECRUITING

University of Arkansas

Little Rock, Arkansas, 72202, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

COMPLETED

Children's Hospital and Health Center

San Diego, California, 92123-4282, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

ACTIVE NOT RECRUITING

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Maine Medical Center

Portland, Maine, 04102, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

RECRUITING

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

RECRUITING

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Ohio State University Children's Hospital

Columbus, Ohio, 43205-2696, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

RECRUITING

University of Tennessee Medical Center at Knoxville

Knoxville, Tennessee, 37920, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232-6305, United States

RECRUITING

University of Texas Southwestern Medical School

Dallas, Texas, 75235-9032, United States

RECRUITING

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2R7, Canada

RECRUITING

University of Manitoba-Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

Herpes Simplex; Herpesviridae Infections; Immune System Diseases; Communicable Diseases; Rare Diseases; Virus Diseases

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

DNA Virus Infections; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David W. Kimberlin

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: August 4, 2000
• Study Start: June 1, 1997
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

CA (2); US (26)