Targeted In Vivo Delivery of Gene Therapeutics for HIV Cure (R01 Clinical Trial Not Allowed) | RFA AI 18 016

Opportunity Information: Apply for RFA AI 18 016

The Targeted In Vivo Delivery of Gene Therapeutics for HIV Cure opportunity (RFA AI 18 016) is a National Institutes of Health (NIH) research grant solicitation that aims to push forward practical, evidence-based methods for getting anti-HIV gene therapies into the right cells inside the body. The core problem this FOA is trying to solve is delivery: even when a gene-based strategy looks strong in a dish or in isolated cells, it often fails to translate because the therapeutic payload cannot be delivered efficiently, selectively, and safely to the relevant HIV target cells in vivo. This announcement is therefore focused on developing and validating innovative delivery approaches that can home to specific target cells and achieve meaningful gene modification where it matters for an HIV cure strategy.

The scientific emphasis is on in vivo targeting and efficiency. In plain terms, NIH is looking for projects that can demonstrate a credible path to delivering gene therapeutics (such as gene editing systems, engineered nucleases, antiviral genes, or other genetic payloads) directly to key HIV-relevant cell populations within living systems, rather than relying on ex vivo manipulation and reinfusion. The work is expected to go beyond concept sketches and into rigorous validation, meaning applicants should be prepared to show measurable delivery performance (for example, the fraction of target cells reached, levels of gene transfer or editing, durability of expression or modification, and impacts on HIV-related outcomes where appropriate), along with a clear strategy for assessing specificity and limiting off-target distribution.

The mechanism is an R01, which generally supports substantial, multi-year research programs with well-developed aims, strong preliminary rationale, and robust experimental plans. This specific R01 is labeled "Clinical Trial Not Allowed," which signals that the funded studies must not be clinical trials in human participants. In practice, that usually means the work should be preclinical or translational in nature, potentially involving lab studies, animal models, and development/optimization of delivery platforms, but stopping short of interventional studies that meet the NIH definition of a clinical trial. Applicants still need to design their research so it produces decision-quality data that could eventually support later-stage translation, but without crossing into clinical trial territory under this FOA.

From an administrative standpoint, this is a discretionary grant program in the health category, offered under NIH CFDA numbers 93.242 and 93.855. The original closing date listed for this opportunity was July 31, 2018, and the creation date was April 20, 2018. An award ceiling is not specified in the provided source data, and the expected number of awards is not listed, which often means applicants should consult the full FOA text and NIH budget guidance to understand typical award sizes and any institute-specific constraints. Even when a formal ceiling is absent, R01 budgets are commonly evaluated for reasonableness relative to the proposed scope of work.

Eligibility is broad and includes many types of U.S. organizations and some non-U.S. entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) entities. Taken together, this reflects NIH's intent to encourage a wide range of capable research performers, including institutions that serve underrepresented populations and organizations outside the continental United States.

Overall, the opportunity is best understood as a targeted push to overcome one of the biggest bottlenecks in HIV gene therapy approaches: getting the therapeutic genetic tool to the right cells in the body with enough efficiency and precision to matter. Competitive applications would be expected to present a delivery concept that is clearly innovative, paired with a realistic and well-validated plan to demonstrate targeted in vivo delivery, quantify performance, and address safety and specificity in a way that moves the field toward workable gene-based HIV cure strategies, all within a non-clinical-trial research framework.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Targeted In Vivo Delivery of Gene Therapeutics for HIV Cure (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.855.
• This funding opportunity was created on 2018-04-20.
• Applicants must submit their applications by 2018-07-31. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AI 18 016

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: