Evaluation of Diagnostic HIV Ag/Ab Combo Assay

NCT00933933 | Completed Phase 3 Results

• 1 other identifier: 7B5-02-06R01
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Human Immunodeficiency Viruses

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations

  3 months

Study Arms (3)

ARCHITECT HIV Ag/Ab Combo Specificity

EXPERIMENTAL

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

ARCHITECT HIV Ag/Ab Combo Sensitivity

NO INTERVENTION

Specimen with confirmed positive HIV Antigen, HIV-1 antibody, or HIV-2 antibody will be tested by the investigational HIV test.

ARCHITECT HIV Ag/Ab Combo Reactivity

EXPERIMENTAL

Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.

Device: ARCHITECT HIV Ag/Ab Combo

Interventions

ARCHITECT HIV Ag/Ab Combo DEVICE

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 Specificity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• HIV infection as affirmed by the subject
• Pregnant Female Population at Risk for HIV Infection:
• Subject is a pregnant female
• Subject has risk factor for HIV infection
• HIV infection as affirmed by the subject
• HIV-1 Positive Pregnant Female Subjects
• Subject is a pregnant female in first, second, or third trimester
• Subject must have documented HIV infection
• None
• HIV-1 Positive Pediatric Subjects
• 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)
• None

Sponsors & Collaborators

• Abbott Diagnostics Division: lead

Study Sites (13)

Radiant Research

Phoenix, Arizona, 85013, United States

Location

Pinellas County Health Dept, Florida Department of Health

St. Petersburg, Florida, 33701, United States

Location

Springfield Clinic, LLP

Springfield, Illinois, 62703, United States

Location

Minneapolis Medical Research Foundation

Minneapolis, Minnesota, 55404, United States

Location

John T. Mather Memorial Hospital

Port Jefferson, New York, 117777, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

M.S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-0609, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Planned Parenthood of Houston and Southeast Texas, Inc.

Houston, Texas, 77004, United States

Location

ARUP Laboratories

Salt Lake City, Utah, 84108-1221, United States

Location

Midwest Research Specialists, LLC

Milwaukee, Wisconsin, 53209, United States

Location

Clement J. Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Barbara Kaesdorf, Associate Director Clinical Affairs
• Organization: Abbott Diagnostic Division

barbara.kaesdorf@abbott.com

847-937-8702

Study Officials

• 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

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

• John Heffner

  Clement J. Zablocki VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 12, 2011
• Results First Posted: August 19, 2010

Record last verified: 2011-07

Locations

US (13)