Evaluation of Diagnostic HIV Ag/Ab Combo Assay

This study has been completed.
Sponsor:
Information provided by:
Abbott Diagnostics Division
ClinicalTrials.gov Identifier:
NCT00933933
First received: July 2, 2009
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Viruses
Device: ARCHITECT HIV Ag/Ab Combo
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of ARCHITECT HIV Ag/Ab Combo Assay

Resource links provided by NLM:


Further study details as provided by Abbott Diagnostics Division:

Primary Outcome Measures:
  • Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 635
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933933

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

No publications provided

Responsible Party: Barbara Kaesdorf, Clinical Project Manager, Abbott Diagnostics Division
ClinicalTrials.gov Identifier: NCT00933933     History of Changes
Other Study ID Numbers: 7B5-02-06R01
Study First Received: July 2, 2009
Results First Received: July 19, 2010
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2014