Recruiting
Phase 3

Acyclovir

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00006132

Conditions

Herpes Simplex

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

acyclovir

Study Details

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

Study ID

NCT00006132

Start date

Jun, 1997

Status verified date

Dec, 2003

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

132 participants

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

acyclovir

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Richard J. Whitley

205-934-5316

University of Alabama Comprehensive Cancer Center

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

David W. Kimberlin

205-939-6097

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Richard Jacobs

501-320-1416

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Elias J. Anaissie

501-686-8274

Children's Hospital and Health Center

Recruiting

San Diego, California, United States, 92123-4282

Contacts

John Bradley

619-576-5823

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Ann Arvin

650-723-5682

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Alberto Cohen-Abbo

860-545-9330

Tulane University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Rusell Van Dyke

504-588-5422

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Carol McCarthy

207-828-8226

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216-4505

Contacts

April Palmer

601-984-5206

St. Louis Children's Hospital

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Gregory Storch

314-454-6079

State University of New York - Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Leonard Weiner

315-464-6331

Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28232-2861

Contacts

Amina Ahmed

704-355-1301

Children's Hospital Medical Center - Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45229-3039

Contacts

Lawrence Stanberry

513-559-6773

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Mary Lou Kumar

216-778-4284

Ohio State University Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205-2696

Contacts

Dwight Powell

614-722-4450

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Penelope H. Dennehy

401-444-4298

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425-0721

Contacts

Sandra Fowler

843-792-2385

University of Tennessee Medical Center at Knoxville

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Thomas Smith

423-544-9356

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232-6305

Contacts

Kathy Edwards

615-322-2250

University of Texas Southwestern Medical School

Recruiting

Dallas, Texas, United States, 75235-9032

Contacts

Pablo J. Sanchez

214-648-3753

Cook Children's Medical Center - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Mark Shelton

817-885-4000

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Gail Demmler

713-770-4330

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78284-7811

Contacts

Charles Leach

210-567-5246

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2R7

Contacts

Joan Robinson

780-492-1680

University of Manitoba-Winnipeg

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Amin Kabani

204-787-1928

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Dec, 2003

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.