# The Long-Acting/Extended Release Antiretroviral Resource Program (LEAP)

> **NIH NIH R24** · JOHNS HOPKINS UNIVERSITY · 2024 · $796,698

## Abstract

The Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP) provides broadly based
scientific support to accelerate the development of novel drugs, formulations, and technologies for the
treatment and prevention of HIV and related epidemics. The LEAP Process to facilitate drug and formulation
development begins with a landscape analysis, identifying knowledge gaps and barriers, simulating best
product characteristics, communicating potential solutions, and then tracking product outcomes. The Program
serves as a focal point for the global conversation on the development of LA/ER formulations, and has brought
many of the world's key stakeholders into this conversation. LEAP's seminal accomplishments include
foundational input for FDA draft guidance on the development of LA/ER formulations for HIV; promoting
development of the first candidate LA/ER formulations for tuberculosis and malaria; organizing the first
conference on use of LA/ER formulations for HIV in children, adolescents, and pregnant women; producing the
first publically accessible website devoted to LA/ER anti-infective products and strategies; and supporting
development of novel devices like anti-HIV implants and microneedles through its Modeling and Simulation
Core. Established in 2015, LEAP is now poised to apply its acquired expertise to new challenges. During the
next five years, we will leverage the infrastructure we have created to: 1) apply our scientific resources to
identify and facilitate development of the most promising new drugs and drug delivery platforms in order to
overcome the limitations of available products; 2) build upon our existing modeling and simulation expertise to
develop better ways to more rapidly identify those approaches with the most desirable pharmacologic
properties; and 3) expand the scope of LEAP to include diseases that overlap the HIV epidemic, where the
availability of LA/ER drugs and formulations could most profoundly affect treatment and prevention –
specifically, tuberculosis, hepatitis B virus, and hepatitis C virus infections. Expected outcomes include an
increased number of new long-acting drugs and formulations in preclinical and clinical development, enhanced
funding mechanisms to bring more such products into testing, and accelerated pathways for more rapid
translation of laboratory-based research into clinical trials and eventual drug approvals.

## Key facts

- **NIH application ID:** 10873262
- **Project number:** 5R24AI118397-10
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Charles W. Flexner
- **Activity code:** R24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $796,698
- **Award type:** 5
- **Project period:** 2015-05-16 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10873262

## Citation

> US National Institutes of Health, RePORTER application 10873262, The Long-Acting/Extended Release Antiretroviral Resource Program (LEAP) (5R24AI118397-10). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10873262. Licensed CC0.

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