Clinical trial NCT02768779: ARV Concentrations in Hair
Official title: IGHID 11601 - Measuring Antiretroviral Concentrations in Hair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: hair
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-05-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hair samples will be collected from HIV negative and positive individuals taking ARVs.

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).

Eligibility criteria: 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

Primary outcomes:
measure: IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with bleach
timeFrame: 1 year
measure: IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with straighteners
timeFrame: 1 year
measure: IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with hair color
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Angela DM Kashuba, PharmD
role: PRINCIPAL_INVESTIGATOR
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