ARV Concentrations in Hair



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/15/2018
Start Date:April 1, 2016
End Date:January 30, 2017

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IGHID 11601 - Measuring Antiretroviral 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.

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).

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
We found this trial at
1
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Chapel Hill, North Carolina 27599
(919) 962-2211
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