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.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000095-41
Application #
6424028
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
41
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
Vanderbilt University Medical Center
Department
Type
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37203

  Publications

Kaltenbach, Karol; O'Grady, Kevin E; Heil, Sarah H et al. (2018) Prenatal exposure to methadone or buprenorphine: Early childhood developmental outcomes. Drug Alcohol Depend 185:40-49
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Gilchuk, Pavlo; Knight, Frances C; Wilson, John T et al. (2017) Eliciting Epitope-Specific CD8+ T Cell Response by Immunization with Microbial Protein Antigens Formulated with ?-Galactosylceramide: Theory, Practice, and Protocols. Methods Mol Biol 1494:321-352
Laird, Chris; Burdorf, Lars; Pierson 3rd, Richard N (2016) Lung xenotransplantation: a review. Curr Opin Organ Transplant 21:272-8
Chung, C P; Ormseth, M J; Connelly, M A et al. (2016) GlycA, a novel marker of inflammation, is elevated in systemic lupus erythematosus. Lupus 25:296-300
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Joy, Nino G; Mikeladze, Maia; Younk, Lisa M et al. (2016) Effects of equivalent sympathetic activation during hypoglycemia on endothelial function and pro-atherothrombotic balance in healthy individuals and obese standard treated type 2 diabetes. Metabolism 65:1695-1705
Gilchuk, Pavlo; Hill, Timothy M; Guy, Clifford et al. (2016) A Distinct Lung-Interstitium-Resident Memory CD8(+) T Cell Subset Confers Enhanced Protection to Lower Respiratory Tract Infection. Cell Rep 16:1800-9
Jones, Hendrée E; Seashore, Carl; Johnson, Elisabeth et al. (2016) Measurement of neonatal abstinence syndrome: Evaluation of short forms. J Opioid Manag 12:19-23

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