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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by G & W Laboratories Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Alquest
SMART Biotech Ltd
Information provided by (Responsible Party):
G & W Laboratories Inc.
ClinicalTrials.gov Identifier:
NCT01447680
First received: September 22, 2011
Last updated: October 9, 2011
Last verified: October 2011
  Purpose

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).


Condition
Human Immunodeficiency Virus Infection
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trial Comparing Two Types of Blood Samples (Plasma and SMARTplasma) for HIV and HCV Antibody Testing

Resource links provided by NLM:


Further study details as provided by G & W Laboratories Inc.:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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.

  • 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). ] [ Designated as safety issue: No ]
    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.

  • 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). ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Plasma and SMARTplasma (SMARTplasma is plasma sample from whole blood treated with SMARTstim)


Estimated Enrollment: 1600
Study Start Date: August 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Blood samples, low risk population
Blood samples, high risk population
Blood samples, known HIV positive

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.
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447680

Contacts
Contact: Aaron Greenblatt, Pharm.D. (908)-753-2000 ext 3803 agreenblatt@gwlabs.com

Locations
United States, Florida
Therafirst Medical Centers Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Anthony LaMarca, M.D.    954-564-4222    director@therafirst.com   
United States, Georgia
American Red Cross Recruiting
Douglasville, Georgia, United States, 30135
Contact: Jose Lima, M.D.    770-852-4023    limaj@usa.redcross.org   
United States, Maryland
Evelyn Jordan Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Lori Fantry, MD    410-328-9105    lfantry@medicine.umaryland.edu   
Reach (Ibr) Completed
Baltimore, Maryland, United States
Man Alive, Inc. Completed
Baltimore, Maryland, United States
University of Maryland, School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Niel Constantine, Ph.D.    410-706-2788    NConstantine@ihv.umaryland.edu   
Principal Investigator: Niel Constantine, Ph.D.         
United States, New York
Bellevue Hospital Recruiting
New York, New York, United States, 10016
Contact: Jessica Jacobson, M.D.    212-562-6184    jessica.jacobson@nyumc.org   
Sponsors and Collaborators
G & W Laboratories Inc.
Alquest
SMART Biotech Ltd
Investigators
Principal Investigator: Niel Constantine, Ph.D. University of Maryland, Baltimore County
  More Information

Publications:
Responsible Party: G & W Laboratories Inc.
ClinicalTrials.gov Identifier: NCT01447680     History of Changes
Other Study ID Numbers: ST-2011-HIV, Version 4
Study First Received: September 22, 2011
Last Updated: October 9, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by G & W Laboratories Inc.:
HIV infection
HCV infection
SMARTube
SMARTplasma

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Immunologic Deficiency Syndromes
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014