CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Hair analysisother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02768779
NCT02768779N/ACompleted
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IGHID 11601 - Measuring Antiretroviral Concentrations in Hair

University of North Carolina, Chapel Hill·observational·Posted May 11, 2016·Updated Jun 13, 2018

In Brief

An observational study evaluating Hair analysis for HIV. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 11, 2016
Enrollment StartApr 1, 2016
Primary CompletionJan 30, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.1 years ago

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.