# Acceptable Multi-user Biodegradable Extended Release (AMBER) Implant System for HIV Prevention

> **NIH NIH R01** · RESEARCH TRIANGLE INSTITUTE · 2021 · $977,476

## Abstract

PROJECT SUMMARY/ABSTRACT
The overarching goal of this proposed program is to develop an innovative, end-user informed HIV pre-
exposure prophylaxis (PrEP) product as an Acceptable Multi-user Biodegradable Extended Release
(AMBER) implant. The implant technology addresses multiple challenges with current PrEP drug delivery
systems (DDS) by offering beneficial attributes: user-independence and discretion of use, zero-order
(sustained) release, long-term protection (≤1 year), retrievability and biodegradation of the polymeric
implant. We propose to engineer the implant to be retrievable throughout the drug delivery period, in the
case of adverse reactions or an end-user’s wish to discontinue. Otherwise, the AMBER implant will remain
in-place and biodegrade after drug depletion. Uniquely, the AMBER implant decouples drug delivery features
from biodegradation properties, which enables zero-order kinetics of drug release. The AMBER program
addresses the goals of this National Institutes of Health (NIH) opportunity (RFA-AI-19-063) for the
development of new and innovative sustained/extended release (SER) DDS for HIV PrEP with novel (non-
tenofovir based) antivirals (ARV). We will inform implant development by eliciting preference insights from
diverse gender, sexual orientation, and ethnic/racial minority populations in two priority geographical areas
under “Ending the HIV Epidemic” initiative in the United States. We propose three specific aims: (1) develop
the AMBER implant with polymers optimized for high durability and bioerosion profiles; (2) formulate selected
ARVs and evaluate safety, pharmacokinetics, and efficacy of lead AMBER implants in preclinical studies;
(3) identify Preferred User Characteristics (PUCs), inform technology development and future deployment of
AMBER into practice by conducting iterative socio-behavioral research with Young MSM, cis- and trans-
gender women in California and Alabama. We will strive to align PUC and key modifiable attributes during
product development: sustained (≤1 year) delivery of novel ARV, polymers designed to optimize
biodegradation timescales, incorporation of end-user acceptability information into a Target Product Profile
(TPP), and evaluation of efficacy in nonhuman primate model. The AMBER program is milestone-driven and
provides defined deliverables to product development efforts to support future needs in clinical translation.

## Key facts

- **NIH application ID:** 10242929
- **Project number:** 5R01AI154549-02
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Leah Johnson
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $977,476
- **Award type:** 5
- **Project period:** 2020-08-20 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10242929

## Citation

> US National Institutes of Health, RePORTER application 10242929, Acceptable Multi-user Biodegradable Extended Release (AMBER) Implant System for HIV Prevention (5R01AI154549-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10242929. Licensed CC0.

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