Measuring HIV drug levels in hair to find missed or stopped doses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.