# NextGen Long-acting and targeted combination ART for Children with HIV

> **NIH NIH R61** · UNIVERSITY OF WASHINGTON · 2020 · $1,026,862

## Abstract

ABSTRACT
The Targeted, Long-acting and Combination Anti-Retroviral Therapeutic (TLC-ART) Program has developed
a scalable, drug-combination nano-platform technology called DcNPs (drug combination nanoparticles) that
enables the stabilizing of insoluble and soluble short-acting antiretroviral drugs together in an injectable
suspension. In nonhuman primates, DcNP is able to transform short-acting oral HIV-drug combinations into
long-acting combinations that can be detected in plasma and cells with no lag phase (i.e., rapid peak drug
concentrations).
This application plans to leverage the novel DcNP technology to develop a safe and effective long-acting
combination antiretroviral therapy for children with HIV. A long-acting injectable is urgently needed for children
who struggle with adherence issues, including pill fatigue or an inability to swallow.
We have established a public-private partnership for the most advanced two active drug TLC-ART platform
evaluation intended for adult treatment through UM1 funding from the NIH. With these invaluable resources,
we plan to create a long-acting monthly injectable formulation for children that includes three active drugs
targeted to two HIV proteins.
Our set of milestone-driven aims is based on a defined target product profile (TPP), and will be guided by an
external advisory board (EAB) through scheduled and on-demand meetings. The research-focused objectives
(Aims 1 and 2) are intended to evaluate a set of four different potential pediatric HIV-drug DcNP combinations
and to select a candidate based on studies in juvenile non-human primates to progress to pre-clinical
development and seek FDA guidance for an accelerated clinical progression plan (Aims 3-6).
The five-year proposal will have EAB and NIAID/DAIDS program oversight to ensure success, and the study
results will form a basis to develop safe and effective long-acting antiviral combinations for treatment of young
children with HIV.

## Key facts

- **NIH application ID:** 9892832
- **Project number:** 1R61AI149665-01
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** RODNEY J.Y. HO
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,026,862
- **Award type:** 1
- **Project period:** 2020-04-06 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9892832

## Citation

> US National Institutes of Health, RePORTER application 9892832, NextGen Long-acting and targeted combination ART for Children with HIV (1R61AI149665-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9892832. Licensed CC0.

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