HIV InfectionsNCT02190578
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test
A study testing Reveal G4 in people with HIV Infections, run by MedMira Laboratories Inc. at 4 sites in United States.
Trial summary
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with patient infected status for HIV-1 (human immunodeficiency virus type 1). Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Reveal G4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,649 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2014to Mar 2015
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All subjects must be at least 18 years of age, able to sign consent form, complete the risk assessment questionnaire, and provide the required blood samples: fingerstick sample (1 drop), venous whole blood sample (1 K2 EDTA tube).
- Population 1 - Individuals at risk of HIV infection (n ≥ 500) Subjects must meet have at least one risk factor for infection with HIV
- Population 2 - Known HIV-1 positive individuals (n ≥ 500) Subjects must be a known HIV-positive individual (previous positive HIV test result)
- Population 3 - Individuals at low risk of HIV infection (n ≥ 500) Subjects must not have any risk factors for infection with HIV
Who cannot join
- Subjects do not meet inclusion criteria
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
Preventive Medicine, University of Southern California (Los Angeles)
Los Angeles, California, 90007
New York City Department of Health and Mental Hygiene
Queens, New York, 11101
Biological Specialty Corporation
Reading, Pennsylvania, 19602
About this study
Official title: Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test for the Detection of HIV-1 Antibodies in Fingerstick and Venous Whole Blood Samples
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with patient infected status for HIV-1 (human immunodeficiency virus type 1).
The study will consist of a single one-hour visit, at which time blood samples will be collected and tested with the investigational device (Reveal G4) and FDA approved comparator assays for detection of HIV-1 antibodies.
Read the detailed description
This clinical trial is a multi-center study to assess the performance characteristics of a rapid in vitro diagnostic assay, the Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4). Specifically, the objective of this study is to determine the sensitivity and specificity of Reveal G4 in finger stick and venous whole blood, relative to FDA approved reference assays for the detection of HIV-1 antibodies.
Approximately 1500-2000 subjects in total will be enrolled in the study across all sites, into three different study populations. Population 1 will be comprised of at least 500 subjects from a population at risk of infection with HIV. Population 2 will be comprised of at least 500 subjects that are known HIV positive individuals. Population 3 will be comprised of at least 500 subjects from a population at low risk of HIV infection. Reveal G4 will be used to test fingerstick whole blood and venous whole blood samples from all study subjects. For enrolled subjects in Populations 1 and 3, who are of unknown HIV antibody status, a plasma sample prepared from the venous whole blood sample will also be tested with an algorithm of FDA-approved assays for the detection of HIV-1 antibodies. For Population 2 subjects who are known HIV-positive individuals, results of previous HIV tests will be obtained from the subjects' medical records. The sensitivity and specificity of Reveal G4 will be determined in fingerstick and venous whole blood relative to HIV-1 antibody status as determined by an algorithm of FDA-approved assays.
The primary analysis will involve comparison of Reveal G4 results for anti-HIV-1 in each sample matrix (fingerstick whole blood and venous whole blood) with the subject's HIV-1 antibody status as determined by FDA-approved assays. Based on the above, the sensitivity and specificity of Reveal G4 will be determined with corresponding two-sided 95% confidence intervals for both fingerstick and venous whole blood.
- Conditions
- HIV Infections
- Being tested
- Reveal G4
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal G4Device
Also called Reveal Rapid HIV-1 Antibody Test
All subjects tested with the investigational device, Reveal G4, plus with an algorithm of approved assays for HIV.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic: Reveal G4 | Experimental | Subjects tested with investigational devices and approved comparator assay algorithms for HIV Receives: Device: Reveal G4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine clinical performance of Reveal G4
To determine the clinical performance of Reveal G4 with fingerstick and venous whole blood relative to the HIV-1 infected status of the patient
Measured: At single study visit (one hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 1,649 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedMira Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabienne Laraque, MD, Principal investigator, New York City Department of Health and Mental HygienePeter Kerndt, MD, Principal investigator, University of Southern California - Los AngelesCheryl Berne, MD, Principal investigator, Biological Specialties CorporationAnthony LaMarca, MD, Principal investigator, Therafirst Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190578
- Sponsor's protocol ID
- MCP005
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2014
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test for the Detection of HIV-1 Antibodies in Fingerstick and Venous Whole Blood Samples
- ClinicalTrials.gov ID
- NCT02190578
- Acronym / sponsor ID
- MCP005
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,649 participants (actual)
- Lead sponsor
- MedMira Laboratories Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Jul 2014 (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.
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with patient infected status for HIV-1 (human immunodeficiency virus type 1).
The study will consist of a single one-hour visit, at which time blood samples will be collected and tested with the investigational device (Reveal G4) and FDA approved comparator assays for detection of HIV-1 antibodies.
Detailed description
This clinical trial is a multi-center study to assess the performance characteristics of a rapid in vitro diagnostic assay, the Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4). Specifically, the objective of this study is to determine the sensitivity and specificity of Reveal G4 in finger stick and venous whole blood, relative to FDA approved reference assays for the detection of HIV-1 antibodies.
Approximately 1500-2000 subjects in total will be enrolled in the study across all sites, into three different study populations. Population 1 will be comprised of at least 500 subjects from a population at risk of infection with HIV. Population 2 will be comprised of at least 500 subjects that are known HIV positive individuals. Population 3 will be comprised of at least 500 subjects from a population at low risk of HIV infection. Reveal G4 will be used to test fingerstick whole blood and venous whole blood samples from all study subjects. For enrolled subjects in Populations 1 and 3, who are of unknown HIV antibody status, a plasma sample prepared from the venous whole blood sample will also be tested with an algorithm of FDA-approved assays for the detection of HIV-1 antibodies. For Population 2 subjects who are known HIV-positive individuals, results of previous HIV tests will be obtained from the subjects' medical records. The sensitivity and specificity of Reveal G4 will be determined in fingerstick and venous whole blood relative to HIV-1 antibody status as determined by an algorithm of FDA-approved assays.
The primary analysis will involve comparison of Reveal G4 results for anti-HIV-1 in each sample matrix (fingerstick whole blood and venous whole blood) with the subject's HIV-1 antibody status as determined by FDA-approved assays. Based on the above, the sensitivity and specificity of Reveal G4 will be determined with corresponding two-sided 95% confidence intervals for both fingerstick and venous whole blood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic: Reveal G4 | Experimental | Device: Reveal G4Subjects tested with investigational devices and approved comparator assay algorithms for HIV |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All subjects must be at least 18 years of age, able to sign consent form, complete the risk assessment questionnaire, and provide the required blood samples: fingerstick sample (1 drop), venous whole blood sample (1 K2 EDTA tube).
Key exclusion criteria (1 listed)
- Subjects do not meet inclusion criteria
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 |
|---|---|---|
| Reveal G4Also: Reveal Rapid HIV-1 Antibody TestAll subjects tested with the investigational device, Reveal G4, plus with an algorithm of approved assays for HIV. | Device | Diagnostic: Reveal G4 |
Primary outcome
Determine clinical performance of Reveal G4
Time frame: At single study visit (one hour)
To determine the clinical performance of Reveal G4 with fingerstick and venous whole blood relative to the HIV-1 infected status of the patient
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 24 Apr 2015.
Related trials for HIV Infections
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.
Fabienne Laraque, MD principal investigator
New York City Department of Health and Mental Hygiene
Peter Kerndt, MD principal investigator
University of Southern California - Los Angeles
Cheryl Berne, MD principal investigator
Biological Specialties Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reveal G4 in people with HIV Infections, run by MedMira Laboratories Inc. at 4 sites in United States.
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 1 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 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Determine clinical performance of Reveal G4 (time frame: At single study visit (one hour)). 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 24 Apr 2015.