Evaluation of Diagnostic HIV Ag/Ab Combo Assay

Evaluation of ARCHITECT HIV Ag/Ab Combo Assay

To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Viruses
• Intervention / Treatment: Device: ARCHITECT HIV Ag/Ab Combo; Device: ARCHITECT HIV Ag/Ab Combo

Detailed Description

All specimens collected under separate specimen collection protocols or obtained from specimen suppliers will be provided to the clinical sites performing the investigational HIV test.

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).

• Study Type: Interventional
• Enrollment (Actual): 635
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Radiant Research
  • Florida
    • St. Petersburg, Florida, United States, 33701
      • Pinellas County Health Dept, Florida Department of Health
  • Illinois
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic, LLP
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minneapolis Medical Research Foundation
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center
    • Port Jefferson, New York, United States, 117777
      • John T. Mather Memorial Hospital
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • M.S. Hershey Medical Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Galveston, Texas, United States, 77555-0609
      • University of Texas Medical Branch at Galveston
    • Houston, Texas, United States, 77004
      • Planned Parenthood of Houston and Southeast Texas, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84108-1221
      • ARUP Laboratories
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • Clement J. Zablocki VA Medical Center
    • Milwaukee, Wisconsin, United States, 53209
      • Midwest Research Specialists, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Normal Healthy Population:

Inclusion Criteria:

• Apparently healthy individual at the time of enrollment as affirmed by the subject

Exclusion Criteria:

• HIV infection as affirmed by the subject

Pregnant Female Population at Risk for HIV Infection:

Inclusion Criteria:

• Subject is a pregnant female
• Subject has risk factor for HIV infection

Exclusion Criteria:

• HIV infection as affirmed by the subject

HIV-1 Positive Pregnant Female Subjects

Inclusion Criteria:

• Subject is a pregnant female in first, second, or third trimester
• Subject must have documented HIV infection

Exclusion Criteria:

• None

HIV-1 Positive Pediatric Subjects

Inclusion Criteria:

• 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:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Device: 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.
No Intervention: 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.
Experimental: ARCHITECT HIV Ag/Ab Combo Reactivity; Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.	Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection	HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.	3 months
Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens	Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.	3 months
Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population	HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.	3 months
Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)	HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations	Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.	3 months

Collaborators and Investigators

• Sponsor: Abbott Diagnostics Division
• Investigators: Principal Investigator: William Roberts, MD, ARUP Laboratories; Principal Investigator: Laurence Demers, PhD, M.S. Hershey Medical Center; Principal Investigator: Fred Apple, PhD, Hennepin Healthcare Research Institute; Principal Investigator: Michael Loeffelholz, PhD, University of Texas Medical Branch at Galveston; Principal Investigator: John Heffner, Clement J. Zablocki VA Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 5, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 7B5-02-06R01