Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth

NCT00006135 | Completed Phase 3

• 2 other identifiers: 199/15334UAB-CASG-104
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 27

Brief Summary

OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth. II. Determine the neurologic outcome in these patients when treated with this regimen. III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR) result when all other CSF parameters remain normal in these patients. IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen. V. Determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients. VI. Determine the safety of this regimen in these patients.

Conditions

Herpes Simplex

Keywords

herpes simplex virus infection; herpesvirus 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 limited to skin, eyes, and mouth; HSV-1 or HSV-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of skin lesions not required); normal CSF indices: WBC less than 22/mm3 and protein less than 115 mg/dL for term infants OR WBC less than 25/mm3 and protein less than 220 mg/dL for preterm infants; no evidence of CNS involvement by CT with contrast, MRI with gadolinium, or head ultrasound; no visceral dissemination (normal liver function tests, normal chest x-ray, etc.); negative CSF PCR result 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; no prior prophylactic acyclovir for risk of herpes simplex virus infection --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 (27)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

University of Arkansas

Little Rock, Arkansas, 72202, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Children's Hospital and Health Center

San Diego, California, 92123-4282, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Ohio State University Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

University of Tennessee Medical Center at Knoxville

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-6305, United States

Location

University of Texas Southwestern Medical School

Dallas, Texas, 75235-9032, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2R7, Canada

Location

University of Manitoba-Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

Location

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
• Allocation: RANDOMIZED
• Masking: DOUBLE
• 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

US (25); CA (2)