Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01 Clinical Trial Not Allowed)

Background
The purpose of this Notice of Funding Opportunity (NOFO) is to support multi-project research programs for the development, characterization, and advancement of gene- and cell-based approaches to achieve long-term remission or elimination of HIV. The Department of Health and Human Services, specifically the National Institutes of Health (NIH), including the National Institute of Allergy and Infectious Diseases (NIAID), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Mental Health (NIMH), is issuing this grant opportunity. The goal is to develop innovative gene- and/or cell-based HIV cure approaches, leveraging recent insights into virus-host interactions, genotype and phenotype of HIV latent cells, and reservoir cell survival and proliferation.

Grant Details
The grant aims to support integrated multi-project research programs applying emerging and improved technologies to the development of innovative gene- and/or cell-based HIV cure approaches. Private sector partnerships are required to facilitate development of strategies appropriate for clinical studies and ultimately commercialization, if proven to be safe and effective. The program structure includes an Administrative Core providing management, coordination, and supervision; optional Scientific Cores providing resources essential for the activities of two or more Research Projects; and required Research Projects integrated in the Program overall. The application must provide a Milestone Plan with timelines for significant research outcomes, criteria for evaluating progress, plans for an INTERACT meeting with the FDA early in product development, a Scientific Advisory Board after award to review progress, annual meetings for all Key Personnel, SAB members and NIAID staff to review goals and milestones achieved during the year.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits with 501(c)(3) IRS status, for-profit organizations including small businesses, local governments, state governments, federal governments, U.S. Territory or Possession entities, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), faith-based or community-based organizations. Foreign organizations are not eligible to apply directly but non-domestic components of U.S. Organizations are eligible. Eligible individuals with the skills necessary to carry out the proposed research as Program Director(s)/Principal Investigator(s) are encouraged to apply.

Period of Performance
The period of performance should reflect the scope of the proposed project with a maximum requested project period of 5 years.

Grant Value
The total funding commitment from NIH components in FY 2025 includes $6.5 million from NIAID, $6.5 million from NHLBI, $0.25 million from NIMH for a total of 3-4 awards. Application budgets are not expected to exceed $2.2M in direct costs per year.