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

Frequently Asked Questions (FAQs)

What is this NIH funding opportunity?

This opportunity is the National Institutes of Health (NIH) program titled "CNS-Targeted Drug Delivery Strategies for HIV (R01 Clinical Trial Not Allowed)" with opportunity number PAR-18-895. It uses the NIH R01 research project grant mechanism.

What is the main purpose of PAR-18-895?

The purpose is to support research that improves how HIV treatments reach and act within the central nervous system (CNS). The central goal is to advance drug delivery approaches that can achieve stronger suppression of HIV in CNS compartments and contribute to reducing HIV reservoirs that persist in or around the brain and spinal cord.

Why does the opportunity focus specifically on the CNS?

The opportunity emphasizes that HIV persistence in the CNS can be difficult to address with standard systemic therapy. Because of biological barriers and other factors, standard approaches may not achieve adequate drug exposure in relevant CNS sites, which can contribute to persistent infection or reservoirs in CNS-related compartments.

What kinds of research activities does NIH expect under this announcement?

Projects are expected to be multidisciplinary and oriented toward developing, optimizing, and evaluating CNS-targeted delivery strategies for antiretroviral (ARV) drugs and biologics. The emphasis is on research that generates actionable knowledge or candidate delivery platforms that could ultimately enable better CNS-targeted HIV therapy.

Are clinical trials allowed under this funding opportunity?

No. This is an "R01 Clinical Trial Not Allowed" opportunity. Applications should focus on preclinical, mechanistic, and translational research activities that do not meet the NIH definition of a clinical trial.

If clinical trials are not allowed, what types of studies fit within scope?

Within the non-clinical-trial scope, applicants are encouraged to propose innovative approaches that enhance CNS penetration, distribution, retention, or controlled release of ARVs or biologic agents. Examples of in-scope research areas mentioned include addressing biological barriers to CNS delivery, exploring formulation or carrier systems, evaluating CNS pharmacokinetics and pharmacodynamics, and studying effects on viral suppression and reservoir-related endpoints in CNS-relevant models.

What therapeutic agents are relevant to this opportunity?

The opportunity specifically references antiretroviral (ARV) drugs and biologic agents (biologics), with the intent of improving their exposure and action within relevant CNS tissues or fluid spaces.

What outcomes or endpoints are emphasized in the announcement?

The announcement emphasizes stronger suppression of HIV in CNS compartments and contributions toward reducing HIV reservoirs persisting in or around the brain and spinal cord. It also points to evaluating how candidate strategies affect viral suppression and reservoir-related endpoints in CNS-relevant models.

What aspects of drug delivery are encouraged for investigation?

NIH highlights strategies to meaningfully increase exposure of ARVs and biologics in relevant CNS sites while maintaining an acceptable safety profile. The opportunity encourages work that improves penetration, distribution, retention, or controlled release in CNS tissues or fluid spaces, and work that addresses biological barriers to CNS delivery.

How important is safety or neurotoxicity in proposed projects?

Safety is explicitly emphasized. Proposed approaches should balance therapeutic benefit against potential toxicity or neurotoxicity, and aim to maintain an acceptable safety profile while increasing CNS exposure of ARVs or biologics.

Does NIH require multidisciplinary or collaborative teams?

Collaborative research partnerships are strongly encouraged due to the complexity of CNS drug delivery and HIV reservoir biology, but collaboration is not stated as a requirement. NIH signals interest in teams integrating expertise across areas such as virology, neuroscience, pharmacology, medicinal chemistry, drug delivery science, bioengineering, and toxicology.

What grant mechanism is being used?

This is a discretionary grant using the NIH R01 funding instrument and is aligned with health research activities.

What are the CFDA numbers associated with this opportunity?

The CFDA numbers listed are 93.242 and 93.855.

When was this funding opportunity created?

The opportunity was created on 2018-08-08.

What is the closing date listed in the provided information?

The original closing date listed is 2021-01-07.

Is the award ceiling specified?

No. The provided source information does not specify an award ceiling.

Is the expected number of awards specified?

No. The provided source information does not specify the expected number of awards.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic applicants and 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 (as described in the announcement, excluding institutions of higher education within those nonprofit categories as stated); for-profit organizations other than small businesses; small businesses; and other entities.

Are minority-serving institutions and other special entity types included as eligible applicants?

Yes. The opportunity explicitly calls out additional eligible applicant types, including 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), and faith-based or community-based organizations.

Are U.S. territories and possessions eligible?

Yes. The opportunity explicitly includes U.S. territories or possessions among the eligible applicant types.

Are federal government agencies eligible to apply?

Yes. Eligible federal government agencies are explicitly listed among the eligible applicant types.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The eligibility information explicitly includes non-domestic (non-U.S.) entities, described as foreign organizations.

Is the program limited to academic institutions?

No. The eligibility list includes a wide range of organizations beyond higher education institutions, including various levels of government, nonprofits, for-profits, small businesses, tribal entities, public housing authorities, community-based organizations, eligible federal agencies, regional organizations, and foreign organizations.

What is the overall expectation for deliverables or impact?

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, especially by improving CNS drug exposure while maintaining acceptable safety.