Hepatitis C Clinical Trial
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 SMARTubeâ„¢ (SMARTstimâ„¢ in the USA).
Status | Completed |
Enrollment | 1600 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Evelyn Jordan Center | Baltimore | Maryland |
United States | Man Alive, Inc. | Baltimore | Maryland |
United States | Reach (Ibr) | Baltimore | Maryland |
United States | University of Maryland, School of Medicine | Baltimore | Maryland |
United States | American Red Cross | Douglasville | Georgia |
United States | Therafirst Medical Centers | Fort Lauderdale | Florida |
United States | Bellevue Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
G & W Laboratories Inc. | Alquest, SMART Biotech Ltd |
United States,
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. — View Citation
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. — View Citation
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. Epub 2004 Apr 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | No |
Secondary | 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). | No |
Secondary | 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). | No |
Secondary | 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). | No |
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