Genetic Engineering Technologies for HIV Cure Research (U19 Clinical Trial Optional) | RFA AI 18 058

Opportunity Information: Apply for RFA AI 18 058

The National Institutes of Health (NIH) funding opportunity titled "Genetic Engineering Technologies for HIV Cure Research (U19 Clinical Trial Optional)" (RFA-AI-18-058) is a discretionary health research program that uses the cooperative agreement mechanism (U19). Its central goal is to push HIV-1 cure research forward by applying modern genetic engineering tools, specifically gene-based and cell-based strategies that could either produce durable, long-term HIV-1 remission without the need for ongoing antiretroviral therapy (ART) or fully eliminate HIV-1 from the body. In other words, the FOA is looking for approaches that move beyond lifelong viral suppression and aim for a functional cure (sustained remission off ART) or a sterilizing cure (complete eradication).

A key feature of this announcement is that it expects projects to span the pipeline from foundational science through translation. Applications are not meant to be purely conceptual or limited to one narrow stage of development. Instead, they are expected to combine basic and/or preclinical work with translational activities, such as test-of-concept studies in relevant animal models and, where appropriate, studies involving human participants. The "clinical trial optional" framing signals that a clinical trial is not required for every application, but the FOA leaves room for clinical testing when it is justified and ready, so applicants can propose either advanced preclinical packages or carefully designed early clinical efforts depending on maturity of the technology.

The FOA also places heavy emphasis on collaboration, specifically requiring a structured partnership between academia and the private sector. That is a deliberate design choice: gene and cell therapies often depend on specialized manufacturing, vector development, delivery platforms, regulatory expertise, and product development capacity that commonly sit in industry, while discovery science and mechanistic studies often sit in academic labs. The announcement is effectively encouraging integrated teams that can iterate from lab-based discoveries to scalable, translatable interventions, rather than isolated projects that stop before real-world feasibility is addressed.

On eligibility, NIH cast a wide net across typical U.S. applicant organizations. Eligible applicants include various levels of government (state, county, city/township, and special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized tribal governments, and tribal organizations that are not federally recognized. It also includes public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3), as long as they are not institutions of higher education), for-profit organizations (other than small businesses), and small businesses. In addition, the FOA explicitly highlights categories of institutions and organizations that NIH often encourages to apply or participate, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, tribal governments other than federally recognized, and U.S. territories or possessions.

The foreign participation rules are more restrictive for who can be the applicant, but still allow international elements in a controlled way. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, the FOA allows "foreign components" as defined by the NIH Grants Policy Statement. Practically, that means a U.S.-based applicant can include certain international collaborations or work performed abroad if it meets NIH definitions and is properly justified and managed under NIH policy.

Administratively, the opportunity is associated with CFDA numbers 93.242 and 93.855, is run by NIH, and was created on 2018-11-29 with an original closing date of 2019-03-11. The listed award ceiling is 175,000, and expected awards are not specified in the provided source. Because this is a cooperative agreement, awardees should generally expect substantial NIH program involvement compared with a standard research project grant. That typically means closer coordination on milestones, progress, and programmatic priorities, which aligns with the FOA's focus on team science, translation, and moving complex genetic engineering approaches toward interventions that could meaningfully change HIV cure research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Genetic Engineering Technologies for HIV Cure Research (U19 Clinical Trial Optional)" 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 2018-11-29.
• Applicants must submit their applications by 2019-03-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $175,000.00 in funding.
• 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.

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