Exploration of Intra-individual Variability of Exposure to Emtricitabine and Lamivudine in Hair to Validate Hair as a Diagnostic Tool for Detecting Partial or Total Non-compliance with Antiretroviral Treatment

What this Trial Is About

Researchers are studying how to better detect if patients living with HIV (PLWHIV) are fully following their antiretroviral treatment schedules by measuring drug levels in hair samples. This study focuses on two common antiretroviral drugs, Emtricitabine and Lamivudine, aiming to understand the variability of drug exposure in different parts of the same hair strand. The goal is to validate hair analysis as a new tool for identifying partial or total non-compliance with treatment, which is often hard to assess through blood or saliva tests alone due to their limitations. Participants in this observational study include HIV patients on stable antiretroviral therapy containing either Emtricitabine or Lamivudine for at least six months. During the study, patients will answer a treatment adherence questionnaire at the start, 3 months, and 6 months. After 6 months, two hair strands will be collected from the base of the scalp to analyze drug concentration variability. This approach avoids invasive blood draws and aims to provide a longer-term picture of medication adherence. Throughout the 6-month follow-up, researchers will evaluate the individuality index for each patient based on hair samples. They will also compare hair drug levels with plasma concentrations and develop a mathematical model to describe their relationship. The study will monitor participation rates and collect adherence data through questionnaires. This research is supported by the University Hospital, Toulouse, and aims to improve methods for monitoring antiretroviral treatment adherence in real-world settings.

Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and/or Total Non-compliance With Treatment