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Preliminary Evaluation of a Point-Of-Care Liver Function Test (DFA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01705041
First Posted: October 12, 2012
Last Update Posted: January 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PATH
  Purpose
The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase test with the standard of care test used in an HIV clinic at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.

Condition Intervention
HIV Tuberculosis Drug-Induced Liver Injury Device: Diagnostics for All liver function test (LFT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preliminary Field Evaluation of a Point-of-Care Transaminase Test

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • percent agreement with gold standard test [ Time Frame: at time of draw ]
    Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.


Enrollment: 700
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostics for All liver function test (LFT)
HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
Device: Diagnostics for All liver function test (LFT)
HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
Other Names:
  • Diagnostics for All (DFA) liver function test (LFT)
  • ALT
  • transaminase

Detailed Description:

The DFA transaminase test provides rapid categorical measurement of ALT in a whole blood specimen taken via finger-stick. The test is based on the platform technology of "paper microfluidics" (also known as "patterned paper"), in which hydrophobic barriers are patterned into a sheet of paper in order to create microfluidic, hydrophilic paths within the paper, through which flow can be directed towards specific detection zones. The test is designed for visual color-coded readout in three ALT ranges ("bins") that correspond to the ranges of AST and ALT (<3x the upper limit of normal (ULN), 3-5x ULN, and >5x ULN) currently used for clinical management decisions per US TB and HIV treatment guidelines. The bin cutoffs are common to treatment guidelines used around the globe, including those used by the Vietnam Ministry of Health.

The colorimetric readout is designed to be read by eye using a visual "read guide" allowing the reader to make a semi-quantitative estimate or assign a categorical value into one of three bins. Alternatively, if the device is scanned (e.g. desk-top scanner) or photographed (e.g. cell phone or standard digital camera, see (9)) and read with image-analysis software, it should be possible to generate a quantitative result. Additionally, multiple control zones notify the user of insufficient sample volume, hemolysis, or damaged reagents.

The overall goal of this study is to conduct a preliminary field evaluation of an investigational transaminase test in a population at risk for DILI. The primary objectives are:

  1. Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.
  2. Determine inter-operator variability.
  3. Determine device failure rate as defined by invalid test results.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 years old) patients receiving HIV treatment through the HTD clinic
  • Must be receiving routine scheduled ALT monitoring on day of enrollment
  • Willing to undergo finger-stick in addition to routine care
  • Must be able to provide informed consent.

Exclusion Criteria:

  • HIV-negative, or HIV-positive but not on treatment
  • Not receiving transaminase monitoring for routine care
  • Unable or unwilling to provide informed consent
  • Less than 18 years old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705041


Locations
Vietnam
Hospital for Tropical Diseases
Ho Chi minh City, Vietnam
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: Nira Pollock, MD,PhD Harvard University
  More Information

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01705041     History of Changes
Other Study ID Numbers: DFA LFT Study
First Submitted: August 21, 2012
First Posted: October 12, 2012
Last Update Posted: January 31, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Tuberculosis
Chemical and Drug Induced Liver Injury
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Liver Extracts
Hematinics