# Testing novel microbicide candidates in sustained release formulations

> **NIH NIH R01** · TULANE UNIVERSITY OF LOUISIANA · 2020 · $653,749

## Abstract

Summary:
Globally, the vast majority of HIV infections occur as a result of vaginal transmission. In the absence of an
effective vaccine, novel HIV prevention strategies are desperately needed. Systemic use of current
antiretroviral treatments is expensive and potentially toxic to recommend for uninfected persons as prevention,
and may result in emergence of resistant HIV strains. However, coitally dependent strategies have failed
either as the result of inadequate safety testing in laboratory animals, or due to marked, and unexpected rates
of non-compliance. Thus to have an actual impact on the HIV epidemic, an optimum prevention strategy must
be safe, non-toxic, inexpensive, and free from the possibility of promoting the emergence of resistant strains. It
also must be deliverable in a manner in which compliance can be assured. The most promising method of
prevention remains an intravaginal ring that can be inserted once every three months and that provides
consistent, sustained delivery of effective concentrations of antiviral drugs incapable of promoting HIV
resistance. Further, the drug must be inexpensive to produce, highly stable at ambient temperatures for
months, and safe with prolonged exposure to mucosal tissues. Here we submit that the latest generation of an
HIV-1 nucleocapsid protein (NCp7) inhibitor called SAMT-247, delivered in a novel intravaginal ring formulation
with unparalleled release characteristics, fits all of these criteria. We will also test the promising integrase
inhibitor dolutegravir (DTG) in combination with SAMT-247 for safety and efficacy in preventing vaginal
transmission, as data suggests it is also is not subject to viral resistance. Here we will test the safety, efficacy,
and duration of protection against multiple high dose vaginal SHIV challenges in a rigorous nonhuman primate
model. We hypothesize a SAMT-247/DTG combination delivered in a novel vaginal ring formulation can
provide safe and sustained protection against repetitive SHIV challenge SHIV for at least 90 days, which would
be a remarkable advance in HIV prevention strategies.

## Key facts

- **NIH application ID:** 10071116
- **Project number:** 5R01AI131433-04
- **Recipient organization:** TULANE UNIVERSITY OF LOUISIANA
- **Principal Investigator:** Ronald S. Veazey
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $653,749
- **Award type:** 5
- **Project period:** 2017-03-15 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10071116

## Citation

> US National Institutes of Health, RePORTER application 10071116, Testing novel microbicide candidates in sustained release formulations (5R01AI131433-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10071116. Licensed CC0.

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