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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
University of Alabama at Birmingham |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00006132 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Simplex |
Drug: acyclovir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 132 |
| Study Start Date: | June 1997 |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to disease (CNS disease with or without cutaneous involvement vs disseminated disease with CNS involvement).
All patients receive acyclovir IV every 8 hours on days 1-21. On day 19, patients undergo a lumbar puncture and must have a negative CSF PCR to be randomized. If patients have a positive CSF PCR on day 19, they continue to receive acyclovir IV every 8 hours. Treatment continues every 7 days with a repeat CSF PCR on the fifth day until a negative CSF PCR result is achieved. Patients are then randomized to one of two treatment arms.
Arm I: Patients receive oral acyclovir three times a day for 6 months. Arm II: Patients receive placebo. In case of cutaneous recurrence during the first 12 months of the study, patients receive open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF PCR is positive) for 5 days. Patients may or may not continue on study drug following this treatment.
Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Children's Hospital of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Richard J. Whitley 205-934-5316 | |
| University of Alabama Comprehensive Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: David W. Kimberlin 205-939-6097 | |
| United States, Arkansas | |
| University of Arkansas | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Richard Jacobs 501-320-1416 | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Elias J. Anaissie 501-686-8274 | |
| United States, California | |
| Cedars-Sinai Medical Center | Completed |
| Los Angeles, California, United States, 90048 | |
| Children's Hospital and Health Center | Recruiting |
| San Diego, California, United States, 92123-4282 | |
| Contact: John Bradley 619-576-5823 | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Ann Arvin 650-723-5682 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Alberto Cohen-Abbo 860-545-9330 | |
| United States, Florida | |
| University of Florida Health Science Center - Jacksonville | Active, not recruiting |
| Jacksonville, Florida, United States, 32209 | |
| United States, Louisiana | |
| Tulane University Medical Center | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Rusell Van Dyke 504-588-5422 | |
| United States, Maine | |
| Maine Medical Center | Recruiting |
| Portland, Maine, United States, 04102 | |
| Contact: Carol McCarthy 207-828-8226 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | Recruiting |
| Jackson, Mississippi, United States, 39216-4505 | |
| Contact: April Palmer 601-984-5206 | |
| United States, Missouri | |
| St. Louis Children's Hospital | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Gregory Storch 314-454-6079 | |
| United States, New York | |
| State University of New York - Upstate Medical University | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Leonard Weiner 315-464-6331 | |
| United States, North Carolina | |
| Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Amina Ahmed 704-355-1301 | |
| United States, Ohio | |
| Children's Hospital Medical Center - Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Lawrence Stanberry 513-559-6773 | |
| MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Mary Lou Kumar 216-778-4284 | |
| Ohio State University Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205-2696 | |
| Contact: Dwight Powell 614-722-4450 | |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Penelope H. Dennehy 401-444-4298 | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425-0721 | |
| Contact: Sandra Fowler 843-792-2385 | |
| United States, Tennessee | |
| University of Tennessee Medical Center at Knoxville | Recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| Contact: Thomas Smith 423-544-9356 | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232-6305 | |
| Contact: Kathy Edwards 615-322-2250 | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Gail Demmler 713-770-4330 | |
| Cook Children's Medical Center - Fort Worth | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Mark Shelton 817-885-4000 | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78284-7811 | |
| Contact: Charles Leach 210-567-5246 | |
| University of Texas Southwestern Medical School | Recruiting |
| Dallas, Texas, United States, 75235-9032 | |
| Contact: Pablo J. Sanchez 214-648-3753 | |
| Canada, Alberta | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 2R7 | |
| Contact: Joan Robinson 780-492-1680 | |
| Canada, Manitoba | |
| University of Manitoba-Winnipeg | Recruiting |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Contact: Amin Kabani 204-787-1928 | |
| Study Chair: | David W. Kimberlin | University of Alabama at Birmingham |
More Information
| Study ID Numbers: | 199/15325, UAB-CASG-103 |
| Study First Received: | August 3, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006132 History of Changes |
| Health Authority: | United States: Federal Government |
|
herpes simplex virus infection herpes virus infection immunologic disorders and infectious disorders rare disease viral infection |
|
Skin Diseases, Viral Virus Diseases Herpes Simplex Anti-Infective Agents Skin Diseases, Infectious Acyclovir |
Skin Diseases Therapeutic Uses DNA Virus Infections Antiviral Agents Pharmacologic Actions Herpesviridae Infections |
