Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing

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).

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Human Immunodeficiency Virus Infection

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 Type: Observational
• Enrollment (Anticipated): 1600

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Therafirst Medical Centers
  • Georgia
    • Douglasville, Georgia, United States, 30135
      • American Red Cross
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, School of Medicine
    • Baltimore, Maryland, United States, 21201
      • Evelyn Jordan Center
    • Baltimore, Maryland, United States
      • Man Alive, Inc.
    • Baltimore, Maryland, United States
      • Reach (Ibr)
  • New York
    • New York, New York, United States, 10016
      • Bellevue Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Laboratory Sample from low risk population (i.e., blood donors), high risk population and known positive patients.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Do not meet the inclusion criteria
• Are enrolled in an HIV vaccine study,
• Who have previously been enrolled in this study

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Blood samples, low risk population
Blood samples, high risk population
Blood samples, known HIV positive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Blood samples for HIV and HCV testing will be collected at time of consent (day 1).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Blood samples for HIV and HCV testing will be collected at time of consent (day 1).

Collaborators and Investigators

• Sponsor: G & W Laboratories Inc.
• Collaborators: Alquest; SMART Biotech Ltd
• Investigators: Principal Investigator: Niel Constantine, Ph.D., University of Maryland, Baltimore

Publications and helpful links

General Publications

• Pilcher 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.
• 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.
• Novikov 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 22, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 4, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: HIV infection; HCV infection; SMARTube; SMARTplasma
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Slow Virus Diseases; HIV Infections; Infections; Hepatitis; Hepatitis A; Hepatitis C; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: ST-2011-HIV, Version 4