# Long-Acting Prevention Implantable System (LAPIS) for HIV Pre-Exposure  Prophylaxis (PrEP)

> **NIH NIH R01** · RESEARCH TRIANGLE INSTITUTE · 2020 · $785,575

## Abstract

PROJECT SUMMARY
The long-term goal of this proposed project is to deliver an innovative, end-user-informed HIV pre-exposure
prophylaxis (PrEP) product in the form of a Long-Acting Prevention Implantable System (LAPIS). LAPIS offers
a combination of attributes that surpass existing delivery systems for PrEP and align with young men and
women's preferences: user independence, discretion, long-term protection (1 year), as well as favorable zero-
order release kinetics of drugs, reversibility over the therapeutic window, delivery of multiple antiretrovirals
(ARVs), and bioerosion of the spent implant to bypass obligatory removal. The implant is uniquely retrievable,
if needed, for the duration of drug delivery, but otherwise remains stationary and biodegrades after depletion of
the drug. In this manner, reversal of drug delivery is possible in the case of adverse reactions or a user's desire
for discontinuation. The implant technology also decouples drug delivery characteristics from biodegradation
properties and can achieve zero-order kinetics of drug release. The LAPIS platform can accommodate different
classes of active pharmaceutical ingredients (APIs) and also enables the delivery of combination ARVs for
PrEP, thereby addressing the potential for increased efficacy (as demonstrated for oral dosing) and providing a
higher barrier for ARV-resistant HIV strains. The proposed specific aims are: (1) To develop an implant system
for delivery of ARVs for HIV PrEP, subcutaneously inserted and lasting 1 year to support adherence, safety,
and effectiveness; (2) To evaluate safety, pharmacokinetics (PK), and in vivo drug depletion profiles of LAPIS
in preclinical studies; and (3) To test the prophylactic efficacy of LAPIS in preventing wild-type and ARV-
resistant simian-human immunodeficiency virus (SHIV) transmission via the penile route within nonhuman
primates (NHPs). Importantly, the proposed work will leverage achievements made during earlier programs in
developing the implant platform and will build upon this work in the following key aspects: long-term active
pharmaceutical ingredient (API) delivery (up to 1 year), delivery of dual APIs, characterization of drug depletion
profiles, and evaluation of prophylactic efficacy in NHPs. Our established and complementary team will use a
Research Strategy that is milestone-driven, with clear expected deliverables guiding progress of product
development and clinical translation.

## Key facts

- **NIH application ID:** 10010563
- **Project number:** 1R01AI152713-01
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Leah Johnson
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $785,575
- **Award type:** 1
- **Project period:** 2020-03-06 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010563

## Citation

> US National Institutes of Health, RePORTER application 10010563, Long-Acting Prevention Implantable System (LAPIS) for HIV Pre-Exposure  Prophylaxis (PrEP) (1R01AI152713-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10010563. Licensed CC0.

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