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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI122319-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV negative and positive individuals | 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. Hair analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with bleach | The effect of bleaching on hair collected from subjects adherence to an ARV regimen for >6 months | 1 year |
| IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with straighteners | The effect of straighteners on hair collected from subjects adherent to an ARV regimen for >6 months | 1 year |
| IR-MALDESI response to ARVs to be validated by LC-MS/MS analysis in hair before and after treatment with hair color | The effect of hair color (dye) on hair collected from subjects adherent to an ARV regimen for >6 months | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Hair samples will be collected from HIV negative and positive individuals taking ARVs.
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| Name | Affiliation | Role |
|---|---|---|
| Angela DM Kashuba, PharmD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15142353 | Background | Adamian MS, Golin CE, Shain LS, DeVellis B. Brief motivational interviewing to improve adherence to antiretroviral therapy: development and qualitative pilot assessment of an intervention. AIDS Patient Care STDS. 2004 Apr;18(4):229-38. doi: 10.1089/108729104323038900. | |
| 23899439 | Background | Adams JL, Patterson KB, Prince HM, Sykes C, Greener BN, Dumond JB, Kashuba AD. Single and multiple dose pharmacokinetics of dolutegravir in the genital tract of HIV-negative women. Antivir Ther. 2013;18(8):1005-13. doi: 10.3851/IMP2665. Epub 2013 Jul 31. |
| Label | URL |
|---|---|
| University of North Carolina website | View source |
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| ID | Term |
|---|---|
| D000081205 | Hair Analysis |
| ID | Term |
|---|---|
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 23111578 | Background | Adams JL, Sykes C, Menezes P, Prince HM, Patterson KB, Fransen K, Crucitti T, De Baetselier I, Van Damme L, Kashuba AD. Tenofovir diphosphate and emtricitabine triphosphate concentrations in blood cells compared with isolated peripheral blood mononuclear cells: a new measure of antiretroviral adherence? J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):260-6. doi: 10.1097/QAI.0b013e3182794723. |
| 20818800 | Background | Agius R, Kintz P; European Workplace Drug Testing Society. Guidelines for European workplace drug and alcohol testing in hair. Drug Test Anal. 2010 Aug;2(8):367-76. doi: 10.1002/dta.147. |
| 17958503 | Background | Allen BC, Hack CE, Clewell HJ. Use of Markov Chain Monte Carlo analysis with a physiologically-based pharmacokinetic model of methylmercury to estimate exposures in US women of childbearing age. Risk Anal. 2007 Aug;27(4):947-59. doi: 10.1111/j.1539-6924.2007.00934.x. |
| 21558490 | Background | Amico KR. Standard of Care for Antiretroviral Therapy Adherence and Retention in Care from the Perspective of Care Providers Attending the 5th International Conference on HIV Treatment Adherence. J Int Assoc Physicians AIDS Care (Chic). 2011 Sep-Oct;10(5):291-6. doi: 10.1177/1545109711406734. Epub 2011 May 10. |
| 16810111 | Background | Amico KR, Fisher WA, Cornman DH, Shuper PA, Redding CG, Konkle-Parker DJ, Barta W, Fisher JD. Visual analog scale of ART adherence: association with 3-day self-report and adherence barriers. J Acquir Immune Defic Syndr. 2006 Aug 1;42(4):455-9. doi: 10.1097/01.qai.0000225020.73760.c2. |
| Background | Amico KR, Mugavero M, Smith L, Crane H, Quinlivan E, Roytburd K, Golin CE, Zinski A, Modi R, Fredericksen R, Keruly J, Montue S. A brief provider survey to characterize retention and adherence standard of care support for patients in HIV care. 9th International Conference on HIV Treatment and Prevention Adherence, Miami FL, June 8-10, 2014. |
| 22079616 | Background | Appenzeller BM, Tsatsakis AM. Hair analysis for biomonitoring of environmental and occupational exposure to organic pollutants: state of the art, critical review and future needs. Toxicol Lett. 2012 Apr 25;210(2):119-40. doi: 10.1016/j.toxlet.2011.10.021. Epub 2011 Oct 31. |
| 22792384 | Background | Arnold EA, Hazelton P, Lane T, Christopoulos KA, Galindo GR, Steward WT, Morin SF. A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection. PLoS One. 2012;7(7):e40603. doi: 10.1371/journal.pone.0040603. Epub 2012 Jul 11. |
| D008919 | Investigative Techniques |