HIV (Human Immunodeficiency Virus)HAIROBSNCT07062614
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
An observational study of HIV (Human Immunodeficiency Virus), run by University Hospital, Toulouse at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- What is being tested?
- Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2025to 30 Jun 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with HIV and receiving antiretroviral therapy with Emtricitabine or Lamivudine.
Who may be able to join
- 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.
Show all 9Show fewer
- Patients over 18 and under 70 years of age.
- Individuals who have not objected.
- Individuals enrolled in the French Health Insurance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Infectious and Tropical Diseases Department, Purpan University Hospital, Toulouse Place du Docteur Baylac
Toulouse, 31059
Emeline Muller, 33 5 61 77 87 07 ext. 33, muller.e@chu-toulouse.fr
About this study
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
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.
Read more
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)
- Being tested
- Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatment
- Keywords
- Antiretroviral treatment, hair, intra-individual variance, HIV, Human immunodeficiency Virus
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with Lamivudine treatment | HIV patients who are on treatment with Lamivudine Receives: Other: Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatment | |
| Patients with Emtricitabine treatment | HIV patients who are on treatment with Emtricitabine Receives: Other: Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individuality index for each patient
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.
Measured: 6 months after the inclusion
Secondary outcomes (3)
Ratio of the mean hair concentration to the plasma antiretroviral concentration
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.
Measured: 6 months after the inclusion
Mathematical model describing the relationship between blood and hair
Nonlinear mixed-effect mathematical/statistical model describing the relationship between blood and hair
Measured: 6 months after the inclusion
Rate of refusal to participate in the study
Number of people who refused to participate in the study because of hair sampling to estimate the difficulties of implementation in a hospital setting.
Measured: 6 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start3 Jul 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062614
- Sponsor's protocol ID
- RC31/24/0574
- Other IDs
- ID-RCB
- Acronym
- HAIROBS
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07062614
- Acronym / sponsor ID
- HAIROBS / RC31/24/0574
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- Antiretroviral treatment, hair, intra-individual variance, HIV, Human immunodeficiency Virus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Lamivudine treatment | – | Other: Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatmentHIV patients who are on treatment with Lamivudine |
| Patients with Emtricitabine treatment | – | Other: Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatmentHIV patients who are on treatment with Emtricitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with HIV and receiving antiretroviral therapy with Emtricitabine or Lamivudine.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair sampling and questionnaires answers for Patients with Lamivudine or Emtricitabine treatmentat 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 | Other | Patients with Emtricitabine treatment, Patients with Lamivudine treatment |
Primary outcome
Individuality index for each patient
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.
3 secondary outcomes
Ratio of the mean hair concentration to the plasma antiretroviral concentration
Time frame: 6 months after the inclusion
Mathematical model describing the relationship between blood and hair
Time frame: 6 months after the inclusion
Rate of refusal to participate in the study
Time frame: 6 months after the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV (Human Immunodeficiency Virus), run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain GUENEAU, MD (33 5 61 77 68 91 ext. 33, gueneau.r@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individuality index for each patient (time frame: 6 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.