National Institute of Allergy & Infectious Diseases, Contract Management Branch, Solar Building, Room 3C07, 6003 Executive Blvd., MSC 7610, Bethesda, MD 20892

A -- PRECLINICAL EVALUATION OF THERAPIES FOR MICROSPORIDIAL INFECTION SOL NIAID-DAIDS-97-02 POC Mr. Phil Hastings, Contract Specialist 301-496-0194 The National Institute of Allergy and Infectious Diseases (NIAID), NIH intends to negotiate with Tulane University for a five-year contract with the Regional Primate Research Center to develop and validate therapies for the treatment of AIDS and associated opportunistic infections using in vitro and in vivo models of microsporidial infection. There currently exists no culture system or animal model of the most common microsporidial pathogen, Enterocytozoon bieneusi, to support pathogenesis and drug discovery research. The in vitro and in vivo models established and validated through this contract will serve to test candidate antibiotics and to provide a standard system to assist pathogenesis, parasite biology, drug resistance and diagnostics research. The Contractor will be responsible for: i) improving, standardizing and validating a proposed model of E. BIENEUSI infection in mice that is suitable for evaluation of potential new therapies for treatment of microsporidial infections; ii) evaluating single agents and/or combination therapies for efficacy in a mouse model of E. BIENEUSI infection using a standardized, reproducible, validated therapeutic protocol defined above; iii) standardizing and validating a proposed IN VITRO system to test new therapies against E. BIENEUSI; iv) screening single agents and/or combinations for efficacy against E. BIENEUSI using a standardized, reproducible, and validated IN VITRO system defined and developed in Item iii above; v) continued improvement and validation of models and protocols for microsporidial infection IN VITRO and IN VIVO for evaluating therapies against E. BIENEUSI; vi) utilizing these models, for specialized studies such as testing therapies with alternative protocols, e.g., using other microsporidial species, alternate routes of infection, prophylaxis protocols, or alternate host cell lines. The Tulane University Regional Primate Research Center is the only known source capable of meeting the requirements of this work; therefore seeking full and open competition would only result in unacceptable delays in fulfilling the requirements of the NIAID. See Numbered Note 22. (0352)

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