ARV Concentrations in Hair

Completed

• Conditions: HIV

• 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

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