ARV Concentrations in Hair

June 11, 2018 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina At Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
The effect of hair color (dye) on hair collected from subjects adherent to an ARV regimen for >6 months
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Angela DM Kashuba, PharmD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

January 30, 2017

Study Completion (Actual)

January 30, 2017

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-0398
  • R01AI122319-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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