National Institute of Allergy & Infectious Diseases, Contract Management Branch, Solar Building, Room 3C07, 6003 Executive Boulevard (MSC 7610), Bethesda, Maryland 20892-7610

A -- SCID-HU (THYMUS/LIVER) ANIMAL MODEL FOR EVALUATING HIV THERAPIES SOL NIAID-DAIDS-96-18 POC Bruce E. Anderson, Contracting Officer (301) 496-8371. The National Institute of Allergy and Infectious Diseases, NIH intends to negotiate with the J. David Gladstone Institutes, located in San Francisco, California, for a 4-year contract to evaluate potential HIV therapeutics in the human tissue-based SCID-hu mouse model developed by Dr. J. Michael McCune. The Contractor will be responsible for i) evaluating therapeutic agents, alone and in combination, for efficacy and toxicity in vitro and in the SCID-hu (thymus/liver) animal model; ii) performing quality assurance/control of the components of the in vitro and in vivo assay systems, to insure reproducible evaluation of candidate therapies, iii) determining optimal routes and schedules of administration; iv) modifying the model system as necessary, to augment its usefulness for evaluating potential HIV therapeutics; and v) preparing and submitting periodic and interim reports. The current contract (N01-AI-55274) utilizes the following material in performance of the contract: 100-150 SCID-hu mice per month (from 2-3 human tissue donors) to be used in groups of 50 for evaluations; and 2 standardized, titered stocks of clinical HIV-1 isolates. This capacity is required. Gladstone 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 Note(s) 22. (0262)

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