Clinical trial NCT01447680: Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing
Official title: Clinical Trial Comparing Two Types of Blood Samples (Plasma and SMARTplasma) for HIV and HCV Antibody Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus Infection
Hepatitis C
Keywords: HIV infection
HCV infection
SMARTube
SMARTplasma
Lead sponsor: G & W Laboratories Inc.
Sponsor class: INDUSTRY
Collaborators: name: Alquest
name: SMART Biotech Ltd
First posted: 2011-10-06
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Laboratory Sample from low risk population (i.e., blood donors), high risk population and known positive patients.

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).

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 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

Primary outcomes:
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)
timeFrame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
Secondary outcomes:
measure: Sensitivity and specificity of HIV and HCV antibody assays when used with SMARTplasma
timeFrame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
measure: Correlation of results from two different sample types (heparin vs EDTA)
timeFrame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
measure: Correlation of results from refrigerated versus frozen then thawed samples
timeFrame: Blood samples for HIV and HCV testing will be collected at time of consent (day 1).
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Centers
state: Florida
city: Douglasville
country: United States
facility: American Red Cross
state: Georgia
city: Baltimore
country: United States
facility: Evelyn Jordan Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: Man Alive, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Reach (Ibr)
state: Maryland
city: New York
country: United States
facility: Bellevue Hospital
state: New York
Study officials:
affiliation: University of Maryland, Baltimore
name: Niel Constantine, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1086/386333. Epub 2004 Apr 28.
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.