Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
Recruitment status was Recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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--
- 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
Contacts and Locations
Show 28 Study Locations| Study Chair: | David W. Kimberlin | University of Alabama at Birmingham |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006132 History of Changes |
| Other Study ID Numbers: | 199/15325, UAB-CASG-103 |
| Study First Received: | August 3, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Research Resources (NCRR):
|
herpes simplex virus infection herpes virus infection immunologic disorders and infectious disorders rare disease viral infection |
Additional relevant MeSH terms:
|
Herpes Simplex Virus Diseases Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious |
Skin Diseases Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013