Measuring HIV drug levels in hair to find missed or stopped doses
Exploration of Intra-individual Variability of Exposure to Emtricitabine and Lamivudine in Hair With a View to Validating the Value of This Matrix as a Diagnostic Tool for Partial and/or Total Non-compliance With Antiretroviral Treatment
This project tries to see if measuring levels of emtricitabine or lamivudine in hair can tell whether adults with HIV are missing doses or have stopped their medicine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT07062614 on ClinicalTrials.gov |
What this trial studies
This observational study recruits adults living with HIV who have been on stable antiretroviral therapy containing emtricitabine or lamivudine for at least six months. Participants agree not to cut their hair below 6 cm over the study period, complete adherence questionnaires, and provide a hair sample at the end of six months. Laboratory analysis will measure antiretroviral concentrations along hair segments to characterize intra-individual variability and compare hair levels with clinical and self-reported adherence data. The goal is to determine whether hair drug concentrations can reliably indicate partial or total non-compliance.
Who should consider this trial
Good fit: Adults aged 18–70 living with HIV who are on a stable regimen containing emtricitabine or lamivudine, enrolled in the French health system, and willing to keep at least 6 cm of hair and provide a hair sample and questionnaire responses.
Not a fit: People not taking emtricitabine or lamivudine, those unwilling or unable to maintain sufficient hair length, and individuals outside the inclusion criteria are unlikely to benefit from this specific approach.
Why it matters
Potential benefit: If successful, this could provide a simple, non-invasive way to detect partial or complete non-adherence to certain HIV medications.
How similar studies have performed: Prior studies have shown that antiretroviral concentrations in hair correlate with adherence and virological outcomes, so this work builds on existing evidence rather than being entirely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient living with HIV * Patient receiving stable antiretroviral therapy (i.e., no change in treatment strategy or dosage regimen) for at least 6 months. * Patient receiving antiretroviral therapy based on emtricitabine or lamivudine. * Patient identified as compliant based on patient follow-up data: (i) patient's reported adherence to the infectious disease physician (i.e., simple self-report), (ii) virological data (i.e., absence of blips in the last 18 months), (iii) pharmacological data (i.e., plasma antiretroviral concentrations within the expected range) if concentrations were previously measured as part of the patient's follow-up. * Patient agreeing not to cut their hair to less than 6 cm of remaining length during the 6 months of the study. * Patient agreeing to have their hair sampled at the end of the 6 months. * Patients over 18 and under 70 years of age. * Individuals who have not objected. * Individuals enrolled in the French Health Insurance Exclusion Criteria: * Pregnant women. * Patients planning to color/bleach their hair in the next 6 months. * Patients planning to have their hair straightened/restyled in the next 6 months. * Persons under judicial protection
Where this trial is running
Toulouse
- Infectious and Tropical Diseases Department, Purpan University Hospital, Toulouse Place du Docteur Baylac — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Romain GUENEAU, MD
- Email: gueneau.r@chu-toulouse.fr
- Phone: 33 5 61 77 68 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.