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Studies antiretroviral drug levels along hair strands in adults with HIV

Measures emtricitabine and lamivudine in hair from adults with HIV.

Key facts

Who runs it
University Hospital, Toulouse
Where
Toulouse, FranceSee the site
Trial code
Registry title
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
Status
Recruiting
People taking part
30 people, planned
Started
3 Jul 2025
Expected to end
30 Jun 2027
Type of study
Observational, 2 groups
Treatments tested
  • Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatment
Record updated
23 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults living with HIV who have taken the same emtricitabine or lamivudine treatment for at least 6 months and take it as prescribed. Hair is sampled at the end of 6 months.

Age
Over 18 and under 70 years
Sex
All sexes
Disease stage
Living with HIV, on stable antiretroviral treatment for at least 6 months
Earlier treatment
Must be on antiretroviral treatment with emtricitabine or lamivudine, with no change in strategy or dose for at least 6 months
Biomarker or test result
Seen as taking treatment as prescribed: self-report, no virus blips in the last 18 months, and blood drug levels in the expected range if measured

Main reasons for not taking part

  • Pregnant women
  • Plans to color or bleach hair in the next 6 months
  • Plans to have hair straightened or restyled in the next 6 months
  • Under judicial protection

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in France

  • Infectious and Tropical Diseases Department, Purpan University Hospital, Toulouse Place du Docteur BaylacToulouse, FranceContact: Emeline MullerTaking people

About the trial

What the trial wants to find out

Treatment adherence is defined by compliance with the dosage schedule (i.e., dose per dose and number of doses per day), as well as the duration of administration (i.e., number of days during which the dosage schedule must be followed).

Read full original descriptionShow less

Treatment adherence determines the therapeutic efficacy and the absence of toxicity of the prescribed medication. However, this adherence is far from being respected even by patients with serious pathologies such as patients living with HIV (PLWHIV). However, among PLWHIV, non-adherence is a significant source of virological failure and is difficult to assess because it is most often based on what the patient reports to their doctor. A currently used approach consists of determining the drug concentration in the blood and possibly that of its metabolite(s). However, determining a drug's blood concentration presents two major pitfalls: (i) it is necessary to take a blood sample, which remains an invasive procedure for the patient; (ii) for the vast majority of drugs, if the patient scrupulously adheres to the dosage schedule a few days before the blood sample is taken, the drug concentration is most often within the expected range. Therefore, a concentration in the reference range does not exclude partial or even total non-compliance between two medical visits. Saliva is a more easily accessible matrix than blood. However, the same representativeness problem is encountered due to the fact that saliva is in almost instantaneous equilibrium with blood.

Urine could be used to assess compliance. However, this requires multiple urine collections between two doses. This constraint is not compatible with the organization of clinical services. The objective is to determine intra-individual variability in the amount of antiretroviral (ARV) in different segments of the same strand of hair during periods of full treatment adherence.

This objective is preliminary to the use of hair as a tool for detecting treatment non-adherence in patients.

Two reference antiretroviral molecules will be documented: Emtricitabine and Lamivudine, as they are present, one or the other, in the majority of antiretroviral combination strategies.

The 2 groups in the trial

  • Patients with Lamivudine treatment

    HIV patients who are on treatment with Lamivudine

    Treatment: Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatment

  • Patients with Emtricitabine treatment

    HIV patients who are on treatment with Emtricitabine

    Treatment: Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Studies antiretroviral drug levels along hair strands in adults with HIVGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07062614, who can take part
Record updated
23 March 2026