Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
635 participants
INTERVENTIONAL
2009-06-30
2009-11-30
Brief Summary
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Detailed Description
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This includes 6252 specimens collected from normal healthy individuals (7B5-02-05Z01-01: Collection of Specimens Used in Abbott Laboratories In Vitro Diagnostic HIV and Hepatitis Assays Clinical Studies)and from specimen suppliers. 588 specimens from HIV-infected pediatric subjects and 448 pregnant females at risk for HIV infection collected under protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay)and from specimen suppliers. All specimens were previously collected and frozen, except for a subset of 586 specimens from normal healthy population and 55 specimen from pregnant females at risk for HIV infection which were collected under separate specimen collection protocols and tested as fresh specimens during the study.
In addition, 83 specimens that were HIV antigen positive, 1121 specimens that were HIV-1 antibody positive, 201 specimens that were HIV-2 antibody positive, and 1409 specimens from US at risk for HIV infection or from HIV-2 endemic area were all obtained from specimen suppliers, except for 11 pediatric specimens collected under a separate protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ARCHITECT HIV Ag/Ab Combo Specificity
Specimens collected from normal apparently healthy individuals at low risk for HIV infection will be tested by the investigational HIV test and FDA-licensed HIV test.
ARCHITECT HIV Ag/Ab Combo
Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.
ARCHITECT HIV Ag/Ab Combo Sensitivity
Specimen with confirmed positive HIV Antigen, HIV-1 antibody, or HIV-2 antibody will be tested by the investigational HIV test.
No interventions assigned to this group
ARCHITECT HIV Ag/Ab Combo Reactivity
Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.
ARCHITECT HIV Ag/Ab Combo
Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible.
Interventions
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ARCHITECT HIV Ag/Ab Combo
Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.
ARCHITECT HIV Ag/Ab Combo
Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible.
Eligibility Criteria
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Inclusion Criteria
* Subject is a pregnant female
* Subject has risk factor for HIV infection
* Subject is a pregnant female in first, second, or third trimester
* Subject must have documented HIV infection
* Subject must be 2 years to 16 years of age
* Subject must have documented HIV infection (e.g., Western blot positive or HIV RNA positive/detectable)
Exclusion Criteria
Pregnant Female Population at Risk for HIV Infection:
* HIV infection as affirmed by the subject
HIV-1 Positive Pregnant Female Subjects
* None
HIV-1 Positive Pediatric Subjects
* None
ALL
Yes
Sponsors
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Abbott Diagnostics Division
INDUSTRY
Responsible Party
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Abbott Diagnostics Division
Principal Investigators
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William Roberts, MD
Role: PRINCIPAL_INVESTIGATOR
ARUP Laboratories
Laurence Demers, PhD
Role: PRINCIPAL_INVESTIGATOR
M.S. Hershey Medical Center
Fred Apple, PhD
Role: PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute
Michael Loeffelholz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Medical Branch at Galveston
John Heffner
Role: PRINCIPAL_INVESTIGATOR
Clement J. Zablocki VA Medical Center
Locations
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Radiant Research
Phoenix, Arizona, United States
Pinellas County Health Dept, Florida Department of Health
St. Petersburg, Florida, United States
Springfield Clinic, LLP
Springfield, Illinois, United States
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States
John T. Mather Memorial Hospital
Port Jefferson, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
M.S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Planned Parenthood of Houston and Southeast Texas, Inc.
Houston, Texas, United States
ARUP Laboratories
Salt Lake City, Utah, United States
Midwest Research Specialists, LLC
Milwaukee, Wisconsin, United States
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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7B5-02-06R01
Identifier Type: -
Identifier Source: org_study_id
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