CNS-Targeted Drug Delivery Strategies for HIV (R01 Clinical Trial Not Allowed) | PAR 18 895

Opportunity Information: Apply for PAR 18 895

This National Institutes of Health (NIH) funding opportunity, titled "CNS-Targeted Drug Delivery Strategies for HIV (R01 Clinical Trial Not Allowed)" (PAR-18-895), supports research aimed at improving how HIV treatments reach and act within the central nervous system (CNS). The core goal is to advance drug delivery approaches that can achieve stronger suppression of HIV in CNS compartments and, importantly, contribute to reducing HIV reservoirs that persist in or around the brain and spinal cord. The opportunity emphasizes that HIV persistence in the CNS can be difficult to address with standard systemic therapy, so proposed projects should focus on strategies that meaningfully increase exposure of antiretroviral (ARV) drugs and biologics in relevant CNS sites while still maintaining an acceptable safety profile.

Projects are expected to be multidisciplinary and oriented toward developing, optimizing, and evaluating delivery strategies rather than conducting clinical trials. The "Clinical Trial Not Allowed" designation signals that applications should focus on preclinical, mechanistic, and translational research activities that do not meet the NIH definition of a clinical trial. Within that scope, applicants are encouraged to propose innovative ways to enhance the penetration, distribution, retention, or controlled release of ARVs or biologic agents in CNS tissues or fluid spaces, with careful attention to balancing therapeutic benefit against potential toxicity or neurotoxicity. In practical terms, that can include work that addresses biological barriers to CNS delivery, explores formulation or carrier systems, evaluates CNS pharmacokinetics and pharmacodynamics, and studies how candidate strategies affect viral suppression and reservoir-related endpoints in CNS-relevant models.

The announcement also highlights that collaborative research partnerships are strongly encouraged, reflecting the complexity of CNS drug delivery and HIV reservoir biology. While collaboration is not required, the program signals clear interest in teams that can integrate expertise such as virology, neuroscience, pharmacology, medicinal chemistry, drug delivery science, bioengineering, and toxicology. The overarching expectation is that proposed approaches will be rigorous and designed to generate actionable knowledge or candidate delivery platforms that can ultimately enable better CNS-targeted HIV therapy.

This is a discretionary grant mechanism using the NIH R01 funding instrument, aligned with health research activities. The CFDA numbers listed for the program are 93.242 and 93.855. The opportunity was created on 2018-08-08, and the original closing date listed is 2021-01-07. The award ceiling and expected number of awards are not specified in the provided source data.

Eligibility is broad and includes many types of domestic applicants as well as certain non-domestic entities. Eligible applicants include state, county, city or township, and 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 governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories as stated); for-profit organizations other than small businesses; small businesses; and other entities. The opportunity explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations).

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "CNS-Targeted Drug Delivery Strategies for HIV (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 2018-08-08.
• Applicants must submit their applications by 2021-01-07. (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 PAR 18 895

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