Infectious and Tropical Diseases Department, Purpan University Hospital, Toulouse Place du Docteur Baylac
Toulouse, 31059, France
Location status: Recruiting
NCT Number: NCT07062614
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Toulouse, 31059, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 months after the inclusion
Determine the individuality index for each patient, defined as:
ID = 1 - (intra-individual variance) / (inter-individual variance) with intra-individual variance being the variation in ARV concentrations in different segments of the same strand of hair within a patient, and inter-individual variance being the variation in ARV concentrations in hair between patients. An individuality index less than 0.2 means that the variability within an individual is as great as that found in a population of individuals treated with the same antiretroviral, i.e., the distribution of this antiretroviral in the hair is too variable to make hair a good tool for assessing adherence.
Time frame: 6 months after the inclusion
Ratio, for each included patient, of the mean hair concentration (over 6 months) to the plasma antiretroviral concentration determined at the 6-month hair collection visit.
Time frame: 6 months after the inclusion
Nonlinear mixed-effect mathematical/statistical model describing the relationship between blood and hair
Time frame: 6 months after the inclusion
Number of people who refused to participate in the study because of hair sampling to estimate the difficulties of implementation in a hospital setting.
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
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
Acronym: HAIROBS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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