Herpes simplex virus causes cold sores (fever blisters) and can lead to painful lesions in the mouth in healthy children. Children with impaired immune systems might develop severe complications. Famvir (famciclovir) is a drug approved to treat herpes simplex and varicella zoster infection in adults. This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age.

Condition	Treatment or Intervention	Phase
Herpes Simplex	Drug: Famvir (famciclovir)	Phase III

Further Study Details: 

Primary Outcomes: Safety; Blood levels

Ages Eligible for Study:  1 Year   -   12 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• History or laboratory evidence of herpes simplex infection
• Clinical evidence or suspicion of herpes simplex infection

Exclusion Criteria:

• Patients unable to swallow
• Concomitant use of probenecid
• Positive pregnancy test

For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-5788 or 1-434-951-3228

Jeffrey Slunt, PhD      434-951-3371    SluntJeffrey@PRAIntl.com

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35233-1711,  United States; Recruiting
California
      Children’s Hospital of San Diego, San Diego,  California,  92123,  United States; Recruiting
Illinois
      Children’s Memorial Hospital, Chicago,  Illinois,  60614,  United States; Recruiting
Kansas
      PRA International, Lenexa,  Kansas,  66219,  United States; Recruiting
Kentucky
      Kosair Charities Pediatric Clinical Research Unit, Louisville,  Kentucky,  40202-3830,  United States; Recruiting
Massachusetts
      Boston University Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
Michigan
      Children’s Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
New York
      State University of New York at, Stony Brook,  New York,  11794-3362,  United States; Recruiting
      Columbia University Medical Center, New York,  New York,  10032,  United States; Recruiting
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Washington
      Children’s Hospital and Regional Medical Center, Seattle,  Washington,  98105,  United States; Recruiting

Study ID Numbers:  CFAM810B2303
Record last reviewed:  March 2005
Last Updated:  March 24, 2005
Record first received:  December 2, 2004
ClinicalTrials.gov Identifier:  NCT00098059
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08