The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with HSV disease of the skin, eyes, and mouth (SEM 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

HSV complicates 1 out of every 3,000 births in the United States. This study focuses on infants with HSV infection isolated to the skin, eyes and mouth (SEM disease). Medication (acyclovir) given through a vein (IV) helps to treat SEM lesions. However, in about half the babies with SEM disease, HSV will come back after IV acyclovir treatment is stopped. HSV may come back in the central nervous system, the SEM or other body organs, causing serious complications. Long-term (6 months) treatment with oral acyclovir following IV acyclovir may reduce the reappearance of HSV disease. In this study, infants initially receive the standard treatment for SEM disease: IV acyclovir for 14 days. Eligible patients are randomized to receive a syrup that contains either acyclovir or placebo (contains no medicine) by mouth for 6 months. Patients are followed for any recurrences of HSV lesions and will receive medical treatment for such lesions. Patients will return to the clinic for follow-up evaluations once a year for 5 years after study treatment is completed.

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

Criteria

INCLUSION CRITERIA:

• Was 28 days of age or less when SEM disease was first diagnosed.
• Weighed at least 800 grams at birth.
• Has documented HSV that has not spread to the central nervous system or other organs of the body.

EXCLUSION CRITERIA:

• Has had bleeding in the brain prior to the study entry.
• Has HSV infection in the central nervous system or other body organs.
• 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) or if the infant is receiving acyclovir expectantly.

Penny Jester      1-877-975-7280    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
      Stanford University, Stanford,  California,  94305,  United States; Recruiting
      Children's Hospital & Health Center - San Diego, San Diego,  California,  92123,  United States; Recruiting
      Cedars-Sinai Medical Center - Los Angeles, Los Angeles,  California,  90048,  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
      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States; Recruiting
North Carolina
      Carolinas Medical Center, Charlotte,  North Carolina,  28204,  United States; Recruiting
Ohio
      Cincinnati Children's Hospital Med Ctr, Cincinnati,  Ohio,  45229,  United States; Recruiting
      MetroHealth Medical Center of Cleveland, Cleveland,  Ohio,  44109,  United States; Recruiting
      Ohio State University, Columbus,  Ohio,  43210,  United States; Recruiting
Oregon
      Oregon Health & Science University, Portland,  Oregon,  97207,  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
      University of Tennessee, Knoxville,  Tennessee,  37920,  United States; Recruiting
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232,  United States; Recruiting
Texas
      Southwestern Medical Center, Dallas,  Texas,  75235,  United States; Recruiting
      University of Texas Health Science Ctr - San Antonio, San Antonio,  Texas,  78229,  United States; Recruiting
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
      Cook - Fort Worth Children's Medical Center, Fort Worth,  Texas,  76104,  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

Study ID Numbers:  97-006
Record last reviewed:  December 2004
Last Updated:  December 29, 2004
Record first received:  March 6, 2002
ClinicalTrials.gov Identifier:  NCT00031447
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08