The purpose of this study is to test whether long-term treatment (6 months) with oral acyclovir improves the outcome for infants with HSV infection of the brain or spinal cord (central nervous system, or CNS disease).

Condition	Treatment or Intervention	Phase
Herpes Simplex	Drug: Acyclovir Oral Suspension  Drug: Zovirax Oral Acyclovir (ACV) Suspension	Phase III

Further Study Details: 

Expected Total Enrollment:  66

Infants diagnosed with HSV disease involving the central nervous system (CNS) are routinely treated with intravenous (IV) acyclovir for 21 days. Infants enrolled in this study will have a spinal tap (a procedure which removes fluid from the spinal column), performed before the end of the IV treatment, to test for HSV improvement. If there is improvement (no evidence of HSV), patients are selected to receive oral acyclovir therapy or placebo for 6 months. If there is evidence of HSV, patients will qualify for a Pilot Sub-study and receive additional IV acyclovir.

Ages Eligible for Study:  up to  24 Months,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

• 28 days of age or less at the time of initial diagnosis of CNS disease.
• Weighed at least 800 grams at birth.
• Has documented CNS disease caused by HSV.
• Has a negative CSF PCR test within 48 hours prior to the completion of the intravenous acyclovir therapy.

EXCLUSION CRITERIA:

• Has had bleeding in the brain prior to the study entry.
• Has poorly functioning kidneys (creatinine greater than 1.5 mg/dL) at time of study enrollment.
• Was born to a woman known to be HIV positive.
• Is being breast-fed and the mother is taking acyclovir, valacyclovir, or famciclovir for more than 120 hours (more than 5 days).
• Infant has HSV infection limited to the skin, eyes, or mouth.
• He or she may qualify for another protocol (DMID 97-006) if the CNS is not involved.

Penny Jester      877-975-7280    PJester@peds.uab.edu

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
Arkansas
      University of Arkansas, Little Rock,  Arkansas,  72201,  United States; Recruiting
California
      Cedars-Sinai Medical Center - Los Angeles, Los Angeles,  California,  90048,  United States; Recruiting
      Stanford University, Stanford,  California,  94305,  United States; Recruiting
      Children's Hospital & Health Center - San Diego, San Diego,  California,  92123,  United States; Recruiting
Connecticut
      Connecticut Children's Medical Ctr, Hartford,  Connecticut,  06119,  United States; Recruiting
Florida
      University of Florida HSC - Jacksonville, Jacksonville,  Florida,  32209,  United States; Recruiting
Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Kentucky
      University of Louisville, Louisville,  Kentucky,  40202-3830,  United States; Recruiting
Louisiana
      Tulane University Medical Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Maine
      Maine Medical Center, Portland,  Maine,  04101,  United States; Recruiting
Maryland
      Johns Hopkins University - Baltimore MD (DIR/IM), Baltimore,  Maryland,  21205,  United States; Recruiting
Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
Mississippi
      University of Mississippi, Jackson,  Mississippi,  39216,  United States; Recruiting
Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States; Recruiting
New York
      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States; Recruiting
North Carolina
      Carolinas Medical Center, Charlotte,  North Carolina,  28204,  United States; Recruiting
Ohio
      MetroHealth Medical Center of Cleveland, Cleveland,  Ohio,  44109,  United States; Recruiting
      Children's Hospital Res Foundation - Columbus, Columbus,  Ohio,  43205,  United States; Recruiting
      Cincinnati Children's Hospital Med Ctr, Cincinnati,  Ohio,  45229,  United States; Recruiting
Oregon
      Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States; Recruiting
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232,  United States; Recruiting
      University of Tennessee, Knoxville,  Tennessee,  37920,  United States; Recruiting
Texas
      University of Texas Health Science Ctr - San Antonio, San Antonio,  Texas,  78229,  United States; Recruiting
      Christus Santa Rosa Health Care, San Antonio,  Texas,  78207,  United States; Recruiting
      Southwest Texas Methodist Hospital, San Antonio,  Texas,  78229,  United States; Recruiting
      Cook - Fort Worth Children's Medical Center, Fort Worth,  Texas,  76104,  United States; Recruiting
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
      University of Texas Southwestern Medical Center, Dallas,  Texas,  75235,  United States; Recruiting
Washington
      Children's Hospital Medical Center of Seattle, Seattle,  Washington,  98105,  United States; Recruiting
Canada, Alberta
      University of Alberta, Edmonton,  Alberta,  T6G2B7,  Canada; Recruiting
Canada, Manitoba
      University of Manitoba - Winnipeg, Winnipeg,  Manitoba,  R3T 2N2,  Canada; Recruiting

Study ID Numbers:  97-007
Record last reviewed:  December 2004
Last Updated:  December 29, 2004
Record first received:  March 6, 2002
ClinicalTrials.gov Identifier:  NCT00031460
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08