# LA HIV Treatment in Pediatrics

> **NIH NIH R61** · RESEARCH TRIANGLE INSTITUTE · 2020 · $995,029

## Abstract

PROJECT SUMMARY
The long-term goal of this proposed project is to develop an innovative, end-user informed Delivery
of Antiretrovirals via Implantable System for Young children (DAISY). DAISY will offer a combination of product
attributes that surpass existing oral regimens for antiretroviral treatment (ART) in young children (ages 2-5):
long-term ART (at least 6 months), reversibility during drug delivery, user independence, biodegradation, and
discretion of use. With a focus on preferred user characteristics in the Republic of South Africa (RSA), the
DAISY platform aims to extend time between clinic visits and simplify dosing regimens of antiretrovirals (ARVs)
in young children to ultimately improve adherence, and thus, viral suppression, disease progression, and
childhood development. The implant is uniquely retrievable, if needed, for the duration of ARV 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 need to change in the regimen. The implant technology
also decouples drug delivery characteristics from biodegradation properties and can achieve zero-order
kinetics of ARV release. The proposed specific aims directly address the goals of this National Institutes of
Health opportunity (RFA-AI-18-057) for innovative long-acting drug delivery systems for treatment of HIV-1
infected children. The specific aims are to (1) develop the DAISY product, including ARV formulations, implant
form factors, and characterization of biodegradation; (2) evaluate safety, pharmacokinetics, and efficacy of
down-selected DAISY prototypes during preclinical studies in New Zealand White rabbits and nonhuman
primates; and (3) inform technology development via iterative socio-behavior research with end-user
populations in RSA. Importantly, the proposed work will leverage achievements made during earlier programs
in developing the implant platform and will build on this work in the following key aspects: long-term delivery
(up to 6 months) of multiple ARVs and incorporation of end-user acceptability data from RSA into a Target
Product Profile. Our Research Strategy is milestone-driven, with clear expected deliverables guiding progress
of product development to align with future clinical translation.

## Key facts

- **NIH application ID:** 9890718
- **Project number:** 1R61AI149499-01
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Mackenzie Cottrell
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $995,029
- **Award type:** 1
- **Project period:** 2020-03-15 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9890718

## Citation

> US National Institutes of Health, RePORTER application 9890718, LA HIV Treatment in Pediatrics (1R61AI149499-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9890718. Licensed CC0.

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