IGHID 11601 - Measuring Antiretroviral Concentrations in Hair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with bleach
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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
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
Secondary Outcomes
No secondary outcomes reported