Human Immunodeficiency Virus InfectionNCT01447680
Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing
An observational study of Human Immunodeficiency Virus Infection and Hepatitis C, run by G & W Laboratories Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™ in the USA). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus Infection, Hepatitis C
- How many people
- 1,600 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2011to Dec 2012
- Phase
- Observational
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Laboratory Sample from low risk population (i.e., blood donors), high risk population and known positive patients.
Who may be able to join
- Adults ages 18-64,
- Are not pregnant
- Not have a life-threatening disease
- Not immunosuppressed (HIV therapy allowed)
- Are able to give consent, and (6) who appear healthy.
Who cannot join
- Do not meet the inclusion criteria
- Are enrolled in an HIV vaccine study,
- Who have previously been enrolled in this study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Evelyn Jordan Center
Baltimore, Maryland, 21201
University of Maryland, School of Medicine
Baltimore, Maryland, 21201
Man Alive, Inc.
Baltimore, Maryland
Reach (Ibr)
Baltimore, Maryland
American Red Cross
Douglasville, Georgia, 30135
Therafirst Medical Centers
Fort Lauderdale, Florida, 33308
Bellevue Hospital
New York, New York, 10016
About this study
Official title: Clinical Trial Comparing Two Types of Blood Samples (Plasma and SMARTplasma) for HIV and HCV Antibody Testing
The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™ in the USA).
Read the detailed description
Following exposure to HIV and HCV, there is a "window period" where a person is infected with the virus but does not produce antibodies at a high enough level so they can be detected by antibody detection test methods. During this time, the person is capable of unknowingly transmitting the virus to others. SMARTstim (SMARTube)is a blood sample additive which pre-treats blood, stimulating antibody production in vitro so as to bring it to detectable levels using ELISA (or any other antibody test method). Accelerated antibody production allows antibody detection in specimens that would otherwise be below the detectable limit of antibody test kits. Plasma samples from blood pretreated with SMARTstim are referred to as "SMARTplasma".
A total of 1,600 blood samples will be collected and tested using an ELISA for HIV and HCV using FDA-approved test kits. The populations include:
- 1000 samples from low risk individuals (blood donors) from 3 geographical locations
- 500 samples from high risk individuals at risk for HIV from 2 geographical locations
- 100 known HIV seropositives
This is a non-linked study; that is, no subject identifiers will be associated with the collected blood. Subjects will not receive any correspondences and will not receive any test results.
If discordant results occur between the plasma and SMARTplasma samples, those samples will be retested. A Western Blot will be performed on ELISA repeat reactive discordant samples. HCV testing using an FDA-approved assay may also be performed using retained samples.
Simple statistical methods will be performed as necessary to analyze concordance of results between the sample types in the same ELISA assay.
Secondarily, it is expected that within the scope of this study, it will be shown that:
- Using SMARTplasma does not adversely affect diagnostic specificity of the HIV and/or HCV antibody assay used; i.e., no increase in the rate of HIV or HCV false positive results.
- Using SMARTplasma does not adversely affect diagnostic sensitivity of the HIV and/or HCV antibody assay used; i.e., no decrease in the number of true positive samples.
- Samples from persons with early or acute infection may show a positive result when using SMARTplasma, while those from plasma will test negative.
- SMARTplasma samples using heparin or EDTA collection tubes and the correlating SMARTstim are comparable.
- SMARTplasma samples that have been frozen show comparable results to correlating SMARTplasma samples that have been refrigerated.
- Keywords
- HIV infection, HCV infection, SMARTube, SMARTplasma
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blood samples, low risk population | Not described | |
| Blood samples, high risk population | Not described | |
| Blood samples, known HIV positive | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of positive and negative results between normal and treated plasma samples when both are tested with the same HIV and/or HCV Enzyme Linked Immunosorbant Assay (ELISA)
There is one timepoint (day 1)for which the primary outcome measure will be assessed and data will be presented. Samples will be collected, delinked and shipped to core lab within 1 day of collection where samples will be processed and subsequently analyzed for HIV and HCV antibodies. Samples will be frozen and retained for future testing. Results of all testing of correlating SMARTplasma and normal plasma samples will be reported as either positive or negative and these results will be compared for concordance.
Measured: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
Secondary outcomes (3)
Sensitivity and specificity of HIV and HCV antibody assays when used with SMARTplasma
Testing to demonstrate that SMARTplasma does not adversely affect diagnostic specificity \& sensitivity of the HIV or HCV antibody assay used (no increase in rate of false positives or false negatives); however,samples from persons with early or acute infection may show a positive result when tested with SMARTplasma while those from normal plasma will test negative. Results of all testing of correlating SMARTplasma and plasma samples will be reported as either positive or negative and these results will be compared for concordance.
Measured: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
Correlation of results from two different sample types (heparin vs EDTA)
Testing will determine if SMARTplasma samples from collections in heparin or ethylenediaminetetraacetic acid (EDTA) tubes and the correlating SMARTstim sample results are comparable. Results of all testing of correlating heparin and EDTA samples will be reported as either positive or negative and these results will be compared for concordance.
Measured: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
Correlation of results from refrigerated versus frozen then thawed samples
Following testing for HIV and HCV antibodies (primary outcome measure), an aliquot of each SMARTplasma test samples will be frozen, thawed and retested for HIV and HCV antibodies side-by-side with a corresponding fresh/refrigerated (non-frozen and thawed) sample. Testing will determine if SMARTplasma samples that have been frozen and thawed prior to testing show comparable results to correlating SMARTplasma samples that have been refrigerated. Results will be reported as either positive or negative and these results will be compared for concordance.
Measured: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G & W Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alquest, SMART Biotech Ltd
- Responsible party
- Sponsor
- Investigators
- Niel Constantine, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447680
- Sponsor's protocol ID
- ST-2011-HIV, Version 4
- Status last verified
- Sep 2015
- First submitted
- 22 Sep 2011
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mumo J, Vansover A, Jehuda-Cohen T. Detecting seronegative-early HIV infections among adult versus student Kenyan blood donors, by using Stimmunology. Exp Biol Med (Maywood). 2009 Aug;234(8):931-9. doi: 10.3181/0812-RM-372. Epub 2009 Jun 2.
PubMed 19491368Pilcher CD, Tien HC, Eron JJ Jr, Vernazza PL, Leu SY, Stewart PW, Goh LE, Cohen MS; Quest Study; Duke-UNC-Emory Acute HIV Consortium. Brief but efficient: acute HIV infection and the sexual transmission of HIV. J Infect Dis. 2004 May 15;189(10):1785-92. doi: 10.1086/386333. Epub 2004 Apr 28.
PubMed 15122514Novikov I, Jehuda-Cohen T. HIV type 1 infection among Ethiopian immigrants to Israel: enhanced in vitro antibody stimulation for estimating the length of the window period. AIDS Res Hum Retroviruses. 2009 Feb;25(2):165-74. doi: 10.1089/aid.2008.0151.
PubMed 19239355
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing Two Types of Blood Samples (Plasma and SMARTplasma) for HIV and HCV Antibody Testing
- ClinicalTrials.gov ID
- NCT01447680
- Acronym / sponsor ID
- ST-2011-HIV, Version 4
- Keywords
- HIV infection, HCV infection, SMARTube, SMARTplasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- G & W Laboratories Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alquest, SMART Biotech Ltd
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Oct 2011 (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 compare the results for HIV and/or Hepatitis C Virus antibody testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™ in the USA).
Detailed description
Following exposure to HIV and HCV, there is a "window period" where a person is infected with the virus but does not produce antibodies at a high enough level so they can be detected by antibody detection test methods. During this time, the person is capable of unknowingly transmitting the virus to others. SMARTstim (SMARTube)is a blood sample additive which pre-treats blood, stimulating antibody production in vitro so as to bring it to detectable levels using ELISA (or any other antibody test method). Accelerated antibody production allows antibody detection in specimens that would otherwise be below the detectable limit of antibody test kits. Plasma samples from blood pretreated with SMARTstim are referred to as "SMARTplasma".
A total of 1,600 blood samples will be collected and tested using an ELISA for HIV and HCV using FDA-approved test kits. The populations include:
- 1000 samples from low risk individuals (blood donors) from 3 geographical locations
- 500 samples from high risk individuals at risk for HIV from 2 geographical locations
- 100 known HIV seropositives
This is a non-linked study; that is, no subject identifiers will be associated with the collected blood. Subjects will not receive any correspondences and will not receive any test results.
If discordant results occur between the plasma and SMARTplasma samples, those samples will be retested. A Western Blot will be performed on ELISA repeat reactive discordant samples. HCV testing using an FDA-approved assay may also be performed using retained samples.
Simple statistical methods will be performed as necessary to analyze concordance of results between the sample types in the same ELISA assay.
Secondarily, it is expected that within the scope of this study, it will be shown that:
- Using SMARTplasma does not adversely affect diagnostic specificity of the HIV and/or HCV antibody assay used; i.e., no increase in the rate of HIV or HCV false positive results.
- Using SMARTplasma does not adversely affect diagnostic sensitivity of the HIV and/or HCV antibody assay used; i.e., no decrease in the number of true positive samples.
- Samples from persons with early or acute infection may show a positive result when using SMARTplasma, while those from plasma will test negative.
- SMARTplasma samples using heparin or EDTA collection tubes and the correlating SMARTstim are comparable.
- SMARTplasma samples that have been frozen show comparable results to correlating SMARTplasma samples that have been refrigerated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood samples, low risk population | – | – |
| Blood samples, high risk population | – | – |
| Blood samples, known HIV positive | – | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Laboratory Sample from low risk population (i.e., blood donors), high risk population and known positive patients.
Key inclusion criteria (5 listed)
- Adults ages 18-64,
- Are not pregnant
- Not have a life-threatening disease
- Not immunosuppressed (HIV therapy allowed)
- Are able to give consent, and (6) who appear healthy.
Key exclusion criteria (3 listed)
- Do not meet the inclusion criteria
- Are enrolled in an HIV vaccine study,
- Who have previously been enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance of positive and negative results between normal and treated plasma samples when both are tested with the same HIV and/or HCV Enzyme Linked Immunosorbant Assay (ELISA)
Time frame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
There is one timepoint (day 1)for which the primary outcome measure will be assessed and data will be presented. Samples will be collected, delinked and shipped to core lab within 1 day of collection where samples will be processed and subsequently analyzed for HIV and HCV antibodies. Samples will be frozen and retained for future testing. Results of all testing of correlating SMARTplasma and normal plasma samples will be reported as either positive or negative and these results will be compared for concordance.
3 secondary outcomes
Sensitivity and specificity of HIV and HCV antibody assays when used with SMARTplasma
Time frame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
Correlation of results from two different sample types (heparin vs EDTA)
Time frame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
Correlation of results from refrigerated versus frozen then thawed samples
Time frame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
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 7 Sep 2015.
- Background: PubMed 19491368Mumo J, Vansover A, Jehuda-Cohen T. Detecting seronegative-early HIV infections among adult versus student Kenyan blood donors, by using Stimmunology. Exp Biol Med (Maywood). 2009 Aug;234(8):931-9. doi: 10.3181/0812-RM-372. Epub 2009 Jun 2.
- Background: PubMed 15122514Pilcher CD, Tien HC, Eron JJ Jr, Vernazza PL, Leu SY, Stewart PW, Goh LE, Cohen MS; Quest Study; Duke-UNC-Emory Acute HIV Consortium. Brief but efficient: acute HIV infection and the sexual transmission of HIV. J Infect Dis. 2004 May 15;189(10):1785-92. doi: 10.1086/386333. Epub 2004 Apr 28.
- Background: PubMed 19239355Novikov I, Jehuda-Cohen T. HIV type 1 infection among Ethiopian immigrants to Israel: enhanced in vitro antibody stimulation for estimating the length of the window period. AIDS Res Hum Retroviruses. 2009 Feb;25(2):165-74. doi: 10.1089/aid.2008.0151.
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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.
Niel Constantine, Ph.D. principal investigator
University of Maryland, Baltimore
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection and Hepatitis C, run by G & W Laboratories Inc. at 7 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 5 inclusion and 3 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Concordance of positive and negative results between normal and treated plasma samples when both are tested with the same HIV and/or HCV Enzyme Linked Immunosorbant Assay (ELISA) (time frame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01447680, which also lists 3 linked publications.
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 7 Sep 2015.