Evaluation of Diagnostic HIV Ag/Ab Combo Assay

Human Immunodeficiency Viruses Clinical Trial

Official title:

Evaluation of ARCHITECT HIV Ag/Ab Combo Assay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933933
• Other study ID #: 7B5-02-06R01
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2009
• Last updated: July 5, 2011
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2011
• Source: Abbott Diagnostics Division
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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:

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:

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Viruses
• Immunologic Deficiency Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	M.S. Hershey Medical Center	Hershey	Pennsylvania
United States	Planned Parenthood of Houston and Southeast Texas, Inc.	Houston	Texas
United States	Clement J. Zablocki VA Medical Center	Milwaukee	Wisconsin
United States	Midwest Research Specialists, LLC	Milwaukee	Wisconsin
United States	Minneapolis Medical Research Foundation	Minneapolis	Minnesota
United States	Radiant Research	Phoenix	Arizona
United States	John T. Mather Memorial Hospital	Port Jefferson	New York
United States	ARUP Laboratories	Salt Lake City	Utah
United States	Springfield Clinic, LLP	Springfield	Illinois
United States	Pinellas County Health Dept, Florida Department of Health	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diagnostics Division

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No