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Phase 3
N/A
28 Days
Not Enrolling
Both
Herpes Simplex

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Trial Information


PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled, multicenter study.

All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days
1-14. On Day 12, patients may undergo a lumbar puncture (at discretion of investigator).
Whole blood is obtained for herpes simplex virus PCR analysis. Upon completion of
intravenous therapy, patients with a negative CSF PCR are randomized to one of two treatment
arms.

Arm I: Patients receive oral acyclovir three times daily for 6 months.

Arm II: Patients receive placebo three times daily for 6 months.

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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

David W. Kimberlin

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

199/15334

NCT ID:

NCT00006135

Start Date:

June 1997

Completion Date:

Related Keywords:

  • Herpes Simplex
  • herpes simplex virus infection
  • herpesvirus infection
  • immunologic disorders and infectious disorders
  • rare disease
  • viral infection
  • Herpes Simplex
  • Virus Diseases

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Stanford UniversityStanford, California  94305
Maine Medical CenterPortland, Maine  04102
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
St. Louis Children's HospitalSaint Louis, Missouri  63110
University of Texas Southwestern Medical SchoolDallas, Texas  75235-9032
Children's Hospital and Health CenterSan Diego, California  92123-4282
MetroHealth Medical CenterCleveland, Ohio  44109
University of Tennessee Medical Center at KnoxvilleKnoxville, Tennessee  37920
University of Florida Health Science Center - JacksonvilleJacksonville, Florida  32209
Tulane University Medical CenterNew Orleans, Louisiana  70112
Ohio State University Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital of AlabamaBirmingham, Alabama  35233
University of ArkansasLittle Rock, Arkansas  72202
Vanderbilt UniversityNashville, Tennessee  37232-6305