HIVDFANCT01705041
Preliminary Evaluation of a Point-Of-Care Liver Function Test
A study testing Diagnostics for All liver function test (LFT) in people with HIV and Tuberculosis, run by PATH at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Tuberculosis, Drug-Induced Liver Injury
- What is being tested?
- Diagnostics for All liver function test (LFT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteVietnam
- Study dates
- Jun 2012to Dec 2012
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Field Evaluation of a Point-of-Care Transaminase Test
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.
Read the 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:
- 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.
- Determine inter-operator variability.
- Determine device failure rate as defined by invalid test results.
- Conditions
- HIV, Tuberculosis, Drug-Induced Liver Injury
- Being tested
- Diagnostics for All liver function test (LFT)
- Medical subject headings
- Tuberculosis, Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostics for All liver function test (LFT)Device
Also called Diagnostics for All (DFA) liver function test (LFT), ALT, transaminase
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)
| Study group | Role | What they receive |
|---|---|---|
| Diagnostics for All liver function test (LFT) | Experimental | 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) Receives: Device: Diagnostics for All liver function test (LFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent agreement with gold standard test
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.
Measured: at time of draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nira Pollock, MD,PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705041
- Sponsor's protocol ID
- DFA LFT Study
- Acronym
- DFA
- Status last verified
- Jan 2013
- First submitted
- 21 Aug 2012
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Field Evaluation of a Point-of-Care Transaminase Test
- ClinicalTrials.gov ID
- NCT01705041
- Acronym / sponsor ID
- DFA / DFA LFT Study
- Conditions
- HIV, Tuberculosis, Drug-Induced Liver Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Determine inter-operator variability.
- Determine device failure rate as defined by invalid test results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostics for All liver function test (LFT) | Experimental | 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostics for All liver function test (LFT)Also: Diagnostics for All (DFA) liver function test (LFT), ALT, transaminaseHIV 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) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nira Pollock, MD,PhD principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostics for All liver function test (LFT) in people with HIV and Tuberculosis, run by PATH at 1 site in Vietnam.
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 4 inclusion and 4 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 31 Jan 2013. 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 Vietnam. 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?
percent agreement with gold standard test (time frame: at time of draw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2013.