Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP-MBP) (U19)

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The purpose of this Funding Opportunity Announcement (FOA) is to support integrated and iterative multi-project, multi-disciplinary preclinical development and exploratory clinical studies with the goal of advancing, strengthening and maintaining an innovative pipeline of non-vaccine biomedical prevention (nBP) strategies, including microbicides, PrEP, and Multipurpose Prevention Technologies (MPT). The focus of the IPCP-MBP is to stimulate and support a strong, diverse base in preclinical discovery and development of nBP candidates that includes development of single and combination nBP delivered pericoitally and by sustained delivery systems to the male and female genital and gastrointestinal (GI) tracts to prevent HIV acquisition/transmission. This objective will be accomplished by supporting the translation of candidates and strategies from preclinical to pre-Phase I clinical studies delivered by a variety of drug delivery systems (DDS), including gels, films, quick dissolving tablets, intravaginal rings (IVR), implants, oral, injection and MPT-based DDS strategies. This FOA has significant modifications to previous offerings of the Integrated Preclinical Clinical Program. Applicants are urged to read the FOA carefully.

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