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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

NCT07062614 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-03-23

No results posted yet for this study

Summary

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).

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.

Conditions

  • HIV (Human Immunodeficiency Virus)

Interventions

OTHER

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

at inclusion, 3 months and 6 months of follow-up, patients must answer the Girerd compliance questionnaire. After 6 months of follow-up, two strands of hair will be taken from the base of the skull using scissors

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2027-02-28
Completion
2027-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07062614 on ClinicalTrials.gov