NCT02768779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

May 4, 2016

Last Update Submit

June 11, 2018

Conditions

HIV

Keywords

hair

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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.

Other: Hair analysis

Interventions

Hair analysisOTHER

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.

HIV negative and positive individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hair samples will be collected from HIV negative and positive individuals taking ARVs.

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects non-adherent to anti-retroviral regimen
  • Subjects not willing or able to provide head hair sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (10)

  • 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.

    PMID: 15142353BACKGROUND

  • 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.

    PMID: 23899439BACKGROUND

  • 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.

    PMID: 23111578BACKGROUND

  • 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.

    PMID: 20818800BACKGROUND

  • 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.

    PMID: 17958503BACKGROUND

  • 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.

    PMID: 21558490BACKGROUND

  • 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.

    PMID: 16810111BACKGROUND

  • 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.

    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.

    PMID: 22079616BACKGROUND

  • 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.

    PMID: 22792384BACKGROUND

Related Links

MeSH Terms

Interventions

Hair Analysis

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Angela DM Kashuba, PharmD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 11, 2016

Study Start

April 1, 2016

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

June 13, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)