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A -- IN VIVO TEST SYSTEMS FOR COMBINED CHEMOTHERAPIES AGAINST HIV POC Bruce Anderson, Contracting Officer 301-496-8371. The National Institute of Allergy and Infectious Diseases intends to negotiate with the J. David Gladstone Foundation for a one-year continuation of the work performed under contract N01-AI-05080. This will be a follow-on contract, for a one year period, 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: 1) evaluating 5-7 therapeutic agents alone and 2 combinations of agents for efficacy in the in vivo model. This includes performance of quality control and statistical analysis of the data; 2) performing additional studies on 2-3 agents and 2 combinations per year in the in vivo model, including pharmacokinetic and toxicology studies and studies to determine optimal routes and schedules of administration; 3) performing in vitro evaluations of 15-20 agents; 4) modifying the model system as necessary, to augment its usefulness for evaluating potential HIV therapeutics, and 5) preparing and submitting periodic and interim reports. The current contract is utilizing the following material in performance of the contract: 150 SCID-hu mice per month (from 4-6 human tissue donors); and, 2 standardized, titered stocks of clinical HIV-isolates. This capacity is required for this continuation. 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. (0100)

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