PLECONARIL (VP63843) THERAPY--INFANTS W/ ENTEROVIRAL MEN

$0M01FY2000RRNIH

Vanderbilt University, Nashville TN

Investigators

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Abstract

HYPOTHESIS: STUDY OBJECTIVES: A) VIROLOGIC EFFICACY- PRIMARY OBJECTIVE of this investigation is to determine if administration of pleconaril to infants w/enteroviral meningitis results in more rapid clearance of virus from various body sites. B) SAFETY- determine the safety of administration of pleconaril to infants w/enteroviral meningitis. The DAIDS Pediatric Toxicity Tables will be utilized. C) PHARMACOKINETICS- the pharmarmacokinetics of pleconaril administered to infants over a seven day period will be defined as a function of age. D) CLINICAL EFFICACY- the effects of pleconaril on resolution of meningitis symptoms will be assessed. SPECIFIC AIMS: STUDY ENDPOINTS: A) PRIMARY- Percentage of patients shedding virus (as detected by viral culture) from the oropharynx (i.e. throat) four days after beginning study drug. B) SECONDARY- 1) Duration (in days) of non-polio enteroviral shedding from any site, as detected by viral culture and/or PCR. 2) Resolution of meningitis symptoms (Appendix III). 3) Safety (see Section IX.D.4 for list of safety labs). 4) Pleconaril pharmacokinetics. C) TERTIARY- Development of viral resistance to pleconaril during course of viral shedding.

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