HIV InfectionsNCT02190305
Rapid Diagnostics for HIV and Hepatitis
A study testing Multiplo HBc/HIV/HCV and Reveal HBsAg in people with HIV Infections and Hepatitis B Infections, run by MedMira Laboratories Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status for HIV-1/2 (human immunodeficiency viruses 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, Hepatitis B Infections, Hepatitis C Infections
- What is being tested?
- Multiplo HBc/HIV/HCV and Reveal HBsAg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2014to Aug 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:
- 13 years of age or older
- able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
- willing to complete the risk assessment questionnaire, and
- willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (K2 EDTA) tubes.
- Population 1 - Diagnostic Trial "At Risk" Group (n = 2000-3000)
Show all 20Show fewer
- Subjects must meet one or more of the following inclusion criteria to be enrolled in Population 1:
- Have at least one risk factor for infection with hepatitis B or C,
- Have at least one risk factor for infection with HIV,
- Present with signs and symptoms of hepatitis,
- Be a known HIV-positive individual (previous positive HIV test result, may comprise up to 500 individuals)
- Population 1A - Additional known HIV-positive individuals (n = ~500)
- Subjects must:
- be a known HIV-positive individual (previous positive HIV test result).
- Population 1B - Additional known HBV-positive individuals (n = ~500)
- Subjects must:
- be known to have current or past HBV infection, as evidenced by HBV serology results.
- Population 1C - Additional known HCV-positive individuals (n = ~500)
- Subjects must:
- be known to be infected with HCV, as evidenced by previous positive HCV test results.
Who cannot join
- Subjects do not meet the inclusion criteria
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Keck School of Medicine - LAUSC
Los Angeles, California, 90089-9239
SCFLD Hepatology Diagnostic Research Laboratory
Miami, Florida, 33136
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, 55404
NYC Dept Health & Mental Hygiene
New York, New York, 11101
About this study
Official title: Rapid Diagnostics for HIV and Hepatitis - Multiplo HBc/HIV/HCV and Reveal HBsAg
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing the results with patient infected status for HBV.
Subject participation in the study will consist of a single one-hour visit, at which time blood samples will be drawn for testing with the investigational devices and with approved comparator assays. The test results, which are the outcome of the study, will be obtained only once, at the time of this visit.
Read the detailed description
The objective of this study is to determine the performance characteristics of two rapid diagnostic tests.
Approximately 3000-4500 subjects in total will be enrolled in the study into four different study populations. In Population 1, which is "at risk" group of about 2000-3000 subjects, roughly 2/3 will be individuals who are at risk of infection with HIV or hepatitis B or C, or who have signs or symptoms of hepatitis. Approximately 500 of these individuals are expected to be known HIV-positive individuals.
The remaining three study populations will be comprised of individuals with known infection with HIV (Population 1A, ~500 individuals), HBV (Population 1B, ~500 individuals), and HCV (Population 1C, ~500 individuals).
Both Multiplo HBc/HIV/HCV and Reveal HBsAg will be used to test finger stick whole blood, venous whole blood and plasma samples from each subject in Population 1. Plasma samples (repository or fresh) will be used to fulfill the requirements for Populations 1A, 1B, and 1C.
For all enrolled subjects, the plasma sample will be tested with the following FDA-approved assays: EIA for anti-HIV-1/2, anti-HCV, anti-HBc total, anti-HBc IgM, anti-HBs, and HBsAg. The efficacy of Multiplo will be determined by comparing the results with patient infected status for HIV-1/2, HBV and HCV. The efficacy of Reveal will be determined by comparing the results with patient infected status for HBV.
The primary analysis will involve comparison of Multiplo HBc/HIV/HCV and Reveal HBsAg results for each of the test markers (anti-HIV-1/2, anti-HCV, anti-HBc, and HBsAg), in each sample matrix (finger stick whole blood, venous whole blood and plasma) with the patient infected status as determined by separate algorithms for HIV, HBV, and HCV. The percent positive and percent negative agreement will be determined relative to patient infected status for each marker and sample type, with corresponding two-sided 95% confidence intervals.
- Being tested
- Multiplo HBc/HIV/HCV and Reveal HBsAg
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplo HBc/HIV/HCV and Reveal HBsAgDevice
Also called Multiplo Rapid HBc/HIV/HCV Antibody Test, Reveal Rapid Hepatitis B Surface Antigen Test
All subjects tested with both investigational devices, plus with algorithms of approved assays for HIV and hepatitis B and C.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg | Experimental | Subjects tested with investigational devices and approved comparator assay algorithms for HIV and hepatitis B and C. Receives: Device: Multiplo HBc/HIV/HCV and Reveal HBsAg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of Reveal HBsAg and Multiplo HBc/HIV/HCV
For each enrolled subject, Multiplo HBc/HIV/HCV and Reveal HBsAg devices will be used to test finger stick whole blood, venipuncture whole blood, and plasma samples. Plasma will also be tested using separate algorithms of FDA approved assays to determine patient infected status for HIV-1/2, hepatitis B, and hepatitis C.
The performance of Reveal HBsAg will be determined relative to patient infected status for hepatitis B for each matrix assessed. The performance of Multiplo HBc/HIV/HCV will be determined relative to patient infected status for each of hepatitis B, HIV-1/2, and hepatitis C.
Measured: At single study visit
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 startMay 2014 (estimated)
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedMira Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Schiff, MD, Principal investigator, University of MiamiPeter Kerndt, MD, Principal investigator, University of Southern California - Los AngelesFabienne Laraque, MD, Principal investigator, New York City Department of Health and Mental Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190305
- Sponsor's protocol ID
- MCP002
- Status last verified
- Apr 2023
- First submitted
- 9 Jul 2014
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostics for HIV and Hepatitis - Multiplo HBc/HIV/HCV and Reveal HBsAg
- ClinicalTrials.gov ID
- NCT02190305
- Acronym / sponsor ID
- MCP002
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedMira Laboratories Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014 (estimated)
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- 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.
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing the results with patient infected status for HBV.
Subject participation in the study will consist of a single one-hour visit, at which time blood samples will be drawn for testing with the investigational devices and with approved comparator assays. The test results, which are the outcome of the study, will be obtained only once, at the time of this visit.
Detailed description
The objective of this study is to determine the performance characteristics of two rapid diagnostic tests.
Approximately 3000-4500 subjects in total will be enrolled in the study into four different study populations. In Population 1, which is "at risk" group of about 2000-3000 subjects, roughly 2/3 will be individuals who are at risk of infection with HIV or hepatitis B or C, or who have signs or symptoms of hepatitis. Approximately 500 of these individuals are expected to be known HIV-positive individuals.
The remaining three study populations will be comprised of individuals with known infection with HIV (Population 1A, ~500 individuals), HBV (Population 1B, ~500 individuals), and HCV (Population 1C, ~500 individuals).
Both Multiplo HBc/HIV/HCV and Reveal HBsAg will be used to test finger stick whole blood, venous whole blood and plasma samples from each subject in Population 1. Plasma samples (repository or fresh) will be used to fulfill the requirements for Populations 1A, 1B, and 1C.
For all enrolled subjects, the plasma sample will be tested with the following FDA-approved assays: EIA for anti-HIV-1/2, anti-HCV, anti-HBc total, anti-HBc IgM, anti-HBs, and HBsAg. The efficacy of Multiplo will be determined by comparing the results with patient infected status for HIV-1/2, HBV and HCV. The efficacy of Reveal will be determined by comparing the results with patient infected status for HBV.
The primary analysis will involve comparison of Multiplo HBc/HIV/HCV and Reveal HBsAg results for each of the test markers (anti-HIV-1/2, anti-HCV, anti-HBc, and HBsAg), in each sample matrix (finger stick whole blood, venous whole blood and plasma) with the patient infected status as determined by separate algorithms for HIV, HBV, and HCV. The percent positive and percent negative agreement will be determined relative to patient infected status for each marker and sample type, with corresponding two-sided 95% confidence intervals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg | Experimental | Device: Multiplo HBc/HIV/HCV and Reveal HBsAgSubjects tested with investigational devices and approved comparator assay algorithms for HIV and hepatitis B and C. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- 13 years of age or older
- able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
- willing to complete the risk assessment questionnaire, and
- willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (K2 EDTA) tubes.
- Population 1 - Diagnostic Trial "At Risk" Group (n = 2000-3000)
Key exclusion criteria (1 listed)
- Subjects do not meet the 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 |
|---|---|---|
| Multiplo HBc/HIV/HCV and Reveal HBsAgAlso: Multiplo Rapid HBc/HIV/HCV Antibody Test, Reveal Rapid Hepatitis B Surface Antigen TestAll subjects tested with both investigational devices, plus with algorithms of approved assays for HIV and hepatitis B and C. | Device | Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg |
Primary outcome
Clinical performance of Reveal HBsAg and Multiplo HBc/HIV/HCV
Time frame: At single study visit
For each enrolled subject, Multiplo HBc/HIV/HCV and Reveal HBsAg devices will be used to test finger stick whole blood, venipuncture whole blood, and plasma samples. Plasma will also be tested using separate algorithms of FDA approved assays to determine patient infected status for HIV-1/2, hepatitis B, and hepatitis C. The performance of Reveal HBsAg will be determined relative to patient infected status for hepatitis B for each matrix assessed. The performance of Multiplo HBc/HIV/HCV will be determined relative to patient infected status for each of hepatitis B, HIV-1/2, and hepatitis C.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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.
Eugene Schiff, MD principal investigator
University of Miami
Peter Kerndt, MD principal investigator
University of Southern California - Los Angeles
Fabienne Laraque, MD principal investigator
New York City Department of Health and Mental Hygiene
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiplo HBc/HIV/HCV and Reveal HBsAg in people with HIV Infections and Hepatitis B 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 20 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: withdrawn, as of the sponsor's last update on 21 Apr 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical performance of Reveal HBsAg and Multiplo HBc/HIV/HCV (time frame: At single study visit). 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 21 Apr 2023.