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AzTrials

HIVNCT02768779

ARV Concentrations in Hair

An observational study of HIV, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Hair analysis
How many people
84 participants
Where
1 siteUnited States
Study dates
1 Apr 2016to 30 Jan 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: 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.

Read the 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).

Conditions
HIV
Being tested
Hair analysis
Keywords
hair

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02768779
Study groupRoleWhat they receive
HIV negative and positive individualsHIV 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.
Receives: Other: Hair analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2016 (estimated)
  2. Study start1 Apr 2016
  3. Primary completion30 Jan 2017
  4. Study completion30 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02768779
Sponsor's protocol ID
16-0398
Other IDs
R01AI122319-01
Status last verified
Jun 2018
First submitted
4 May 2016
Last updated
13 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15142353

  • 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.

    PubMed 23899439

  • 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.

    PubMed 23111578

  • 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.

    PubMed 20818800

  • 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.

    PubMed 17958503

  • 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.

    PubMed 21558490

  • 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.

    PubMed 16810111

  • 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.

  • 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.

    PubMed 22079616

  • 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.

    PubMed 22792384

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02768779, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.

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