ARV Concentrations in Hair

Completed

• Conditions: HIV
• Interventions: Other: Hair analysis

• Registration Number: NCT02768779
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Primary Completion: 2017-01-30
• Study Completion: 2017-01-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV negative and positive individuals	Hair analysis	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States