A platform for monitoring the efficacy and optimal dosing of long-acting ART

Summary

Develop and validate a novel pharmacologic monitoring platform for long-acting antiretroviral therapy (ART) using at-home self-collections and point-of-care (POC) testing to optimize dosing and patient management in real-world settings.

What they want

The project aims to address challenges in long-acting ART dosing by developing a monitoring platform. This involves validating at-home self-collection methods and point-of-care testing for cabotegravir/rilpivirine (CAB/RPV) concentrations using miniature mass spectrometry. The project will classify drug concentrations in a longitudinal cohort of persons with HIV (PWH) to define pharmacokinetic parameters and establish strategies for personalized dose intervals, including the development of a clinician-friendly interface for dose calculation.

Deliverables

Validated assays for at-home self-collections and POC testing of CAB/RPV concentrations
Classification of CAB/RPV concentrations (low, expected, high) and defined pharmacokinetic parameters (within- and between-person variability) in a real-world longitudinal cohort
Identified ideal drug concentration testing strategy
Established pharmacokinetic strategies for personalized dose intervals
Easy-to-use interface for clinicians to calculate personalized dosing

Technical requirements

At-home self-collections
Point-of-care (POC) testing
Quantitative cabotegravir/rilpivirine (CAB/RPV) concentration measurement
Miniature mass spectrometry
FDA bioanalytical guidance compliance for assay validation
Pharmacokinetic (PK) parameter definition
Development of an easy-to-use interface/application for clinicians