Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs

Phase 0 Completed 30 enrolled Rhonda Brand National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupOpen-labelOther

Summary

This is a single-center, open label study to identify adherence levels of commonly prescribed FDA-approved antiretroviral agents by tracking the decline of drug concentrations in plasma, urine and saliva following abrupt drug cessation in HIV-negative adults. Results from this study may provide support for development of a point of care urine testing device to monitor drug adherence.

Timeline

Start: 2020-08-31
Primary completion: 2021-09-30
Completion: 2021-09-30

Publications

Else LJ, Dickinson L, Edick S, Zyhowski A, Ho K, Meyn L, Dilly-Penchala S, Thompson B, Shaw V, Khoo S, Brand RM. Tenofovir, emtricitabine, lamivudine and dolutegravir concentrations in plasma and urine following drug intake cessation in a randomized controlled directly observed pharmacokinetic trial to aid point-of-care testing. J Antimicrob Chemother. 2024 Jul 1;79(7):1597-1605. doi: 10.1093/jac/dkae147.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dolutegravir	Other / unclassified	50 mg	Oral
Subject	Lamivudine	Other / unclassified	300 mg	Oral
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Subject	emtricitabine	Other / unclassified	200 mg	Oral
Subject	tenofovir alafenamide	Small molecule	25 mg	Oral

Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs

Summary

Timeline

Publications

Drugs

Indications