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CompletedNCT00933933Updated Jul 12, 2011Results posted

Evaluation of Diagnostic HIV Ag/Ab Combo Assay

A Phase 3 interventional study of ARCHITECT HIV Ag/Ab Combo and ARCHITECT HIV Ag/Ab Combo in Human Immunodeficiency Viruses, sponsored by Abbott Diagnostics Division. Completed at 13 sites in United States. Per ClinicalTrials.gov, last updated 2011-07-12.

Sponsored by Abbott Diagnostics Division (part of Abbott) · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
635
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Human Immunodeficiency Viruses
03

In context

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's enrollment of 635 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Abbott Diagnostics Division is the lead sponsor of 8 studies on the registry; none are open to participants now.

Browse Abbott Diagnostics Division studies →All Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
635 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceARCHITECT 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.

  • DeviceARCHITECT 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

07

Results

Posted Aug 19, 2010

Participant flow

All specimens collected under separate collection protocols or obtained from specimen suppliers: human immunodeficiency virus (HIV) antigen positive samples, HIV-1 antibody positive, specimens collected from individuals at risk for HIV infection in the United States (US), HIV-2 antibody positive and specimens collected from HIV-2 endemic area.

General Population From 16 to 89 Years
Participant flow — General Population From 16 to 89 Years
MilestoneArchitect HIV Ag/Ab Combo SpecificityArchitect HIV Ag/Ab Combo SensitivityArchitect HIV Ag/Ab Combo Reactivity
Started616412871206
Completed616412671206
Not completed0200
Withdrew: Did not meet criteria for analysis0200
Pregnant Females Between 16-44 Years
Participant flow — Pregnant Females Between 16-44 Years
MilestoneArchitect HIV Ag/Ab Combo SpecificityArchitect HIV Ag/Ab Combo SensitivityArchitect HIV Ag/Ab Combo Reactivity
Started44867203
Completed44865203
Not completed020
Withdrew: Specimens classified incorrectly020
Pediatric From 2 to 21 Years
Participant flow — Pediatric From 2 to 21 Years
MilestoneArchitect HIV Ag/Ab Combo SpecificityArchitect HIV Ag/Ab Combo SensitivityArchitect HIV Ag/Ab Combo Reactivity
Started588640
Completed588640
Not completed000

Outcome measures

PrimaryArchitect 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.

Time frame:
3 months
Reported as:
Number · Blood Specimens
Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
Blood SpecimensArchitect HIV Ag/Ab Specificity - Low Risk for HIV Infection
HIV Ag/Ab Combo Reactive, HIV status Positive37 (99.62 to 99.88)
HIV Ag/Ab Combo Reactive, HIV status Negative14
HIV Ag/Ab Combo Nonreactive HIV status Positive0
HIV Ag/Ab Combo Nonreactive HIV status Negative6113
Statistical analysis
  • Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection · Exact binomial · Clinical specificity: 99.77 · 95% CI 99.62 to 99.88
PrimaryArchitect 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.

Time frame:
3 months
Reported as:
Number · Blood specimens
Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens
Blood specimensHIV p24 Antgen SensitivityHIV-1 Antibody SensitivityHIV-2 Antibody Sensitivity
ARCHITECT HIV Ag/Ab Reactive631003201
ARCHITECT HIV Ag/Ab Nonreactive000
Statistical analysis
  • HIV p24 Antgen Sensitivity · Exact binomial · Clinical sensitivity: 100.00 · 95% CI 94.31 to 100.00
  • HIV-1 Antibody Sensitivity · Exact binomial · Clinical sensitivity: 100.00 · 95% CI 99.63 to 100.00
  • HIV-2 Antibody Sensitivity · Exact binomial · Clinical sensitivity: 100.00 · 95% CI 98.18 to 100.00
PrimaryArchitect 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.

Time frame:
3 months
Reported as:
Number · Blood specimens
Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population
Blood specimensArchitect HIV Ag/Ab Combo Specificity in Pregnant FemalesArchitect HIV Ag/Ab Combo Sensitivity in Pregnant Females
Architect HIV Ag/Ab Reactive065
Architect HIV Ag/Ab Nonreactive4480
Statistical analysis
  • Architect HIV Ag/Ab Combo Specificity in Pregnant Females · Exact binomial · Clinical specificity: 100.00 · 95% CI 99.18 to 100.00
  • Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females · Exact binomial · Clinical sensitivity: 100.00 · 95% CI 94.48 to 100.00
PrimaryArchitect 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.

Time frame:
3 months
Reported as:
Number · Blood specimens
Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)
Blood specimensArchitect HIV Ag/Ab Combo Specificity in Pediatric PopulationArchitect HIV Ag/Ab Combo Sensitivity in Pediatric Population
HIV Ag/Ab Combo Reactive HIV Status Positive064
HIV Ag/Ab Combo Reactive HIV Status Negative10
HIV Ag/Ab Combo Nonreactive HIV Status Positive00
HIV Ag/Ab Combo Nonreactive HIV Status Negative5870
Statistical analysis
  • Architect HIV Ag/Ab Combo Specificity in Pediatric Population · Exact binomial · Clinical specificity: 99.83 · 95% CI 99.06 to 100.00
  • Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population · Exact binomial · Clinical sensitivity: 100.00 · 95% CI 94.40 to 100.00
SecondaryArchitect 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.

Time frame:
3 months
Reported as:
Number · Blood specimens
Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations
Blood specimensIncreased Risk for HIV in US PopulationIncreased Risk for HIV From HIV-2 Endemic AreaReactivity in Pregnant Female Population
HIV Ag/Ab Combo Reactive HIV Status Positive65835
HIV Ag/Ab Combo Reactive HIV Status Negative660
HIV Ag/Ab Combo Nonreactive - HIV Status Positive000
HIV Ag/Ab Combo Nonreactive HIV Status Negative622424198

Adverse events

Collected over Device adverse events were collected during the approximate 3 months of testing with Architect HIV Combo assay.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Architect HIV Ag/Ab Combo Specificity—0/586 (0%)0/586 (0%)
Architect HIV Ag/Ab Combo Sensitivity———
Architect HIV Ag/Ab Combo Reactivity—0/55 (0%)0/55 (0%)

Baseline characteristics

Age, Customized
Age, Customized(participants)Architect HIV Ag/Ab Combo SpecificityArchitect HIV Ag/Ab Combo HIV-1 Antigen SensitivityArchitect Ag/Ab Combo HIV-1 Antibody SensitivityArchitect HIV Ag/Ab Combo HIV-2 Antibody SensitivityArchitect HIV Ag/Ab Combo ReactivityTotal
between 2 and 21 years588064061713
>= 21 years566301057013048024
Not collected183020144329
Sex/Gender, Customized
Sex/Gender, Customized(participants)Architect HIV Ag/Ab Combo SpecificityArchitect HIV Ag/Ab Combo HIV-1 Antigen SensitivityArchitect Ag/Ab Combo HIV-1 Antibody SensitivityArchitect HIV Ag/Ab Combo HIV-2 Antibody SensitivityArchitect HIV Ag/Ab Combo ReactivityTotal
Female4165023105304926
Male2087089008793856
Not collected08302010284
Region of Enrollment
Region of Enrollment(Participants)Architect HIV Ag/Ab Combo SpecificityArchitect HIV Ag/Ab Combo HIV-1 Antigen SensitivityArchitect Ag/Ab Combo HIV-1 Antibody SensitivityArchitect HIV Ag/Ab Combo HIV-2 Antibody SensitivityArchitect HIV Ag/Ab Combo ReactivityTotal
United States625278112108968347
Côte D'Ivoire000201513714
South Africa040004
Cameroon010001
08

Study locations

13 sites
  • Radiant Research
    Phoenix, Arizona 85013, United States
  • Pinellas County Health Dept, Florida Department of Health
    St. Petersburg, Florida 33701, United States
  • Springfield Clinic, LLP
    Springfield, Illinois 62703, United States
  • Minneapolis Medical Research Foundation
    Minneapolis, Minnesota 55404, United States
  • John T. Mather Memorial Hospital
    Port Jefferson, New York 117777, United States
  • Jacobi Medical Center
    The Bronx, New York 10461, United States
  • M.S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • University of Texas Medical Branch at Galveston
    Galveston, Texas 77555-0609, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
  • Planned Parenthood of Houston and Southeast Texas, Inc.
    Houston, Texas 77004, United States
  • ARUP Laboratories
    Salt Lake City, Utah 84108-1221, United States
  • Midwest Research Specialists, LLC
    Milwaukee, Wisconsin 53209, United States
  • Clement J. Zablocki VA Medical Center
    Milwaukee, Wisconsin 53295, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2009, a primary completion of Oct 2009 and a completion of Nov 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2010, 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2009
First posted
Jul 7, 2009
Start
Jun 2009
Primary completionActual
Oct 2009
CompletionActual
Nov 2009
Results first posted
Aug 19, 2010
Last update
Jul 12, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00933933
Lead sponsor
Abbott Diagnostics Division
First posted
Jul 7, 2009
Start date
Jun 2009
Primary completion
Oct 2009
Completion
Nov 2009
Results posted
Aug 19, 2010
Last update
Jul 12, 2011

Study contacts

William Roberts, MD
principal investigator · ARUP Laboratories
Laurence Demers, PhD
principal investigator · M.S. Hershey Medical Center
Fred Apple, PhD
principal investigator · Hennepin Healthcare Research Institute
Michael Loeffelholz, PhD
principal investigator · The University of Texas Medical Branch, Galveston
John Heffner
principal investigator · Clement J. Zablocki VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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