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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Alabama at Birmingham |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00006132 |
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 |
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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.
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--
Study Chair: | David W. Kimberlin | University of Alabama at Birmingham |
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 |
Virus Diseases Herpes Simplex Skin Diseases, Infectious Acyclovir Skin Diseases |
Rare Diseases DNA Virus Infections Antiviral Agents Herpesviridae Infections |
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 |