Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of Famvir in children 1-12 years of age.

Condition	Treatment or Intervention	Phase
Chickenpox Herpes Zoster	Drug: famciclovir (Famvir)	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:

• Male or female children 1-12 years of age
• Clinical or laboratory evidence of varicella zoster infection
• Patients suspected of having varicella zoster infection

Exclusion Criteria:

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

For detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228

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

Kansas
      PRA International, Lenexa,  Kansas,  66219,  United States
New York
      Columbia University Medical Center, New York,  New York,  10032,  United States
Costa Rica
      Instituto de Atencion Pediatrica, San Jose,  Costa Rica
Guatemala
      Hospital Infantil de Infectologia y Rehabilitacion, Ciudad de Guatemala,  Guatemala
Panama
      Hospital del Nino, Panama City,  Panama

Study ID Numbers:  CFAM810B2304
Record last reviewed:  December 2004
Last Updated:  December 8, 2004
Record first received:  December 2, 2004
ClinicalTrials.gov Identifier:  NCT00098046
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08