ARV Concentrations in Hair

Study Overview
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Brief Summary
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Hair samples from subjects on antiretroviral therapy, both HIV- and HIV+ patients with HIV RNA <50copies/mL for >6 months will be analyzed to investigate the influence of race, hair color and hair treatment on ARV response.

Detailed Description
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A small thatch of hair (approximately 20 strands) will be collected from 85 participants who are currently taking antiretrovirals (ARVs). Hair collection will be evenly distributed into color cohorts: Black, Brown, Blonde and Grey. Participants will need to be >80% adherent to their medication and have had an undetectable HIV RNA VL within the previous 6 months. In the lab, samples will be used to develop IR-MALDESI MSI hair protocols for high sensitivity and accuracy to quantify ARVs in 5 therapeutic drug classes (Integrase Inhibitors, Nucleoside Reverse Transcriptase Inhibitors, Non-Nucleoside Reverse Transcriptase Inhibitors, Entry Inhibitors, Protease Inhibitors).

Official Title
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IGHID 11601 - Measuring Antiretroviral Concentrations in Hair

Conditions
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HIV

Intervention / Treatment
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* Other: Hair analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV Negative or HIV positive individuals, aged 18 years or older, who have been taking their ARV medication for at least 3 months and are adherent based on blood plasma HIV RNA of <50 copies/mL or HIV negative status. Exclusion Criteria: Subjects non-adherent to anti-retroviral regimen Subjects not willing or able to provide head hair sample

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV negative and positive individuals<br>HIV Negative or HIV positive individuals, aged 18 years or older, who have been taking their ARV medication for at least 3 months and are adherent based on blood plasma HIV RNA of <50 copies/mL or HIV negative status. Hair analysis. | Other: Hair analysis<br>* Within the laboratory, experimental factors controlling IR-MALDESI response to key ARVs representing various drug classes will be systematically evaluated using the design of experiments (DOE) statistical approach (41,127) for an unbiased optimization of IRMALDESI response to each of the ARVs and their major metabolites. The goal will be to achieve a lower limit of quantification (LLOQ) below clinically relevant hair strand concentrations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with bleach | The effect of bleaching on hair collected from subjects adherence to an ARV regimen for >6 months | 1 year | 
| IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with straighteners | The effect of straighteners on hair collected from subjects adherent to an ARV regimen for >6 months | 1 year | 
| IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with hair color | The effect of hair color (dye) on hair collected from subjects adherent to an ARV regimen for >6 months | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hair