Preliminary Evaluation of a Point-Of-Care Liver Function Test

NCT ID: NCT01705041

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-12-31

Brief Summary

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.

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.

Conditions

HIV; Tuberculosis; Drug-Induced Liver Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Diagnostics for All liver function test (LFT)

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

Diagnostics for All (DFA) liver function test (LFT); ALT; transaminase

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nira Pollock, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

Hospital for Tropical Diseases

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Other Identifiers

DFA LFT Study

Identifier Type: -

Identifier Source: org_study_id