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

NCT01447680 | Completed

• 1 other identifier: ST-2011-HIV, Version 4
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Human Immunodeficiency Virus Infection; Hepatitis C

Keywords

HIV infection; HCV infection; SMARTube; SMARTplasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity and specificity of HIV and HCV antibody assays when used with SMARTplasma

  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)

  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

  Blood samples for HIV and HCV testing will be collected at time of consent (day 1).

Study Arms (3)

Blood samples, low risk population

Blood samples, high risk population

Blood samples, known HIV positive

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Are enrolled in an HIV vaccine study,
• Who have previously been enrolled in this study

Sponsors & Collaborators

• G & W Laboratories Inc.: lead
• Alquest: collaborator
• SMART Biotech Ltd: collaborator

Study Sites (7)

Therafirst Medical Centers

Fort Lauderdale, Florida, 33308, United States

Location

American Red Cross

Douglasville, Georgia, 30135, United States

Location

Evelyn Jordan Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland, School of Medicine

Baltimore, Maryland, 21201, United States

Location

Man Alive, Inc.

Baltimore, Maryland, United States

Location

Reach (Ibr)

Baltimore, Maryland, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

Related Publications (3)

• 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.

  PMID: 19491368 BACKGROUND

• 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.

  PMID: 15122514 BACKGROUND

• 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.

  PMID: 19239355 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis C; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Niel Constantine, Ph.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: October 6, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

US (7)