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Completed

NCT Number: NCT02768779

ARV Concentrations in Hair

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hair analysis

Other

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.

Primary outcomes

  1. IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with bleach

    Time frame: 1 year

    The effect of bleaching on hair collected from subjects adherence to an ARV regimen for >6 months

  2. IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with straighteners

    Time frame: 1 year

    The effect of straighteners on hair collected from subjects adherent to an ARV regimen for >6 months

  3. IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with hair color

    Time frame: 1 year

    The effect of hair color (dye) on hair collected from subjects adherent to an ARV regimen for >6 months

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)

Registry information

Official study title

IGHID 11601 - Measuring Antiretroviral Concentrations in Hair

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2016
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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