# LASER ART for PreP

> **NIH NIH R01** · UNIVERSITY OF NEBRASKA MEDICAL CENTER · 2021 · $710,244

## Abstract

Abstract
This project contains a highly collaborative investigative team with interdisciplinary expertise with significant
potential impact for HIV/AIDS prevention. The proposal includes pharmacologic, virologic, animal and product
development studies designed to halt disease transmission through novel long-acting (LA) antiretrovirals.
These are named LA slow effective release antiretroviral therapies (LASER ART) designed to facilitate HIV-1
prevention by intense bench to the clinic translational studies. Innovative interdisciplinary approaches contain
a detailed research plan, extensive preliminary and broadly published supportive data. Creativity and
innovativeness are offered placed at higher risk than a conventional research project. The work builds on the
development of parenteral nanoformulations of chemically modified antiretroviral drugs designed to improve
adherence. The drugs are currently offered once/day in pill form but will be converted to up to once a year
administration. Support from expert pharmacologists and pharmaceutical scientists with University researchers
are operative. The drugs include dolutegravir (DTG), emtricitabine (FTC) and tenofovir (TFV) created to extend
their apparent drug half-life, efficacy and abilities to target viral reservoirs. They are, in measure, DTG and FTC
and TFV prodrug + nucleotide (ProTides) designated “N” for nanoformulation, “M” for esterification and “P” for
ProTides. The created NPFTC and NPTFV and NM2DTG demonstrate sustained plasma and tissue drug
concentrations of > 90% inhibitory concentration from months to a year. Based on encouraging results, we
seek funds to facilitate large scale development that would facilitate future human studies. The final
formulations would be characterized by sustained prodrug hydrolysis with reduced injection volumes. The
pathway forward follows established partnership with the Clinton Health Access Initiative and oversight by ViiV
Healthcare and Gilead Sciences. The overarching goal is safety, reproducibility and “scale-up” that follows US
Food and Drug Administration-approved current good manufacturing practices (cGMP). The specific aims are
each supported by extensive published data sets forged through the multidisciplinary research. Creation and
characterization focus on prodrug formulations, toxicology, and pharmacokinetics profiles follow a safe
developmental action plan. The work is facilitated by a fully operational cGMP facility and rhesus macaque
validations. The lead formulation will be developed with our CHAI partners. We posit that the creation of
LASER ART DTG or FTC and TFV will have a profound impact on HIV prevention.

## Key facts

- **NIH application ID:** 10259156
- **Project number:** 1R01AI158160-01A1
- **Recipient organization:** UNIVERSITY OF NEBRASKA MEDICAL CENTER
- **Principal Investigator:** Benson Edagwa
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $710,244
- **Award type:** 1
- **Project period:** 2021-04-12 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10259156

## Citation

> US National Institutes of Health, RePORTER application 10259156, LASER ART for PreP (1R01AI158160-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10259156. Licensed CC0.

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