Human Immunodeficiency VirusesPhase 3NCT00933933

Evaluation of Diagnostic HIV Ag/Ab Combo Assay

A Phase 3 study testing ARCHITECT HIV Ag/Ab Combo in people with Human Immunodeficiency Viruses, run by Abbott Diagnostics Division at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Viruses
What is being tested?: ARCHITECT HIV Ag/Ab Combo
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 635 participants
Where: 13 sitesUnited States
Study dates: Jun 2009to Nov 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Apparently healthy individual at the time of enrollment as affirmed by the subject
Subject is a pregnant female
Subject has risk factor for HIV infection
Subject is a pregnant female in first, second, or third trimester
Subject must have documented HIV infection
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)

Who cannot join

HIV infection as affirmed by the subject
Pregnant Female Population at Risk for HIV Infection:
HIV infection as affirmed by the subject
HIV-1 Positive Pregnant Female Subjects
None
HIV-1 Positive Pediatric Subjects
None

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

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

Other trials in United States

About this study

Official title: Evaluation of ARCHITECT HIV Ag/Ab Combo Assay

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).

Conditions: Human Immunodeficiency Viruses
Being tested: ARCHITECT HIV Ag/Ab Combo
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARCHITECT HIV Ag/Ab ComboDevice
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 ComboDevice
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.

Study groups in NCT00933933
Study group	Role	What they receive
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. Receives: 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. Receives: Device: ARCHITECT HIV Ag/Ab Combo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Nov 2009

First posted7 Jul 2009 (estimated)
Study startJun 2009
Primary completionOct 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Immunodeficiency VirusesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 635 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00933933
Sponsor's protocol ID: 7B5-02-06R01
Status last verified: Jul 2011
First submitted: 2 Jul 2009
Last updated: 12 Jul 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All Human Immunodeficiency Viruses trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of ARCHITECT HIV Ag/Ab Combo Assay
ClinicalTrials.gov ID: NCT00933933
Acronym / sponsor ID: 7B5-02-06R01
Conditions: Human Immunodeficiency Viruses
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 635 participants (actual)
Lead sponsor: Abbott Diagnostics DivisionIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Oct 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 7 Jul 2009 (estimated)
Results: Posted 19 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ARCHITECT HIV Ag/Ab Combo Specificity	Experimental	Device: ARCHITECT HIV Ag/Ab ComboSpecimens 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.
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	Device: ARCHITECT HIV Ag/Ab ComboSpecimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Apparently healthy individual at the time of enrollment as affirmed by the subject
Subject is a pregnant female
Subject has risk factor for HIV infection
Subject is a pregnant female in first, second, or third trimester
Subject must have documented HIV infection

Key exclusion criteria (7 listed)

HIV infection as affirmed by the subject
HIV infection as affirmed by the subject
HIV-1 Positive Pregnant Female Subjects
None
HIV-1 Positive Pediatric Subjects

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ARCHITECT HIV Ag/Ab ComboTest 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 Specificity
ARCHITECT HIV Ag/Ab ComboTest 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.	Device	ARCHITECT HIV Ag/Ab Combo Reactivity

Primary outcome

Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
Time frame: 3 months
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
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
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
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.

1 secondary outcome

Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations
Time frame: 3 months

Results and safety

Results posted to the registry on 19 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Architect HIV Ag/Ab Combo Specificity	6,164	6,164
Architect HIV Ag/Ab Combo Sensitivity	1,287	1,267
Architect HIV Ag/Ab Combo Reactivity	1,206	1,206

Primary outcome: Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection

Time frame: 3 months. Number. Unit: Blood Specimens

Measure	Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection n = 6164
HIV Ag/Ab Combo Reactive, HIV status Positive	37 (99.62 to 99.88)
HIV Ag/Ab Combo Reactive, HIV status Negative	14
HIV Ag/Ab Combo Nonreactive HIV status Positive	0
HIV Ag/Ab Combo Nonreactive HIV status Negative	6113

Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection: Clinical Specificity: 99.77 (95% CI 99.62 to 99.88), Exact binomial

Population analysed: Specificity determined from 6,164 specimens from apparently healthy individuals (low risk): includes 250 specimens from pregnant females in first trimester and 580 specimens from low risk population prospectively collected and tested fresh during study. Total of 37 confirmed HIV positives by supplemental testing were excluded from analysis.

Primary outcome: Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens

Time frame: 3 months. Number. Unit: Blood specimens

Measure	HIV p24 Antgen Sensitivity n = 63	HIV-1 Antibody Sensitivity n = 1003	HIV-2 Antibody Sensitivity n = 201
ARCHITECT HIV Ag/Ab Reactive	63	1003	201
ARCHITECT HIV Ag/Ab Nonreactive	0	0	0

HIV p24 Antgen Sensitivity: Clinical Sensitivity: 100.00 (95% CI 94.31 to 100.00), Exact binomial
HIV-1 Antibody Sensitivity: Clinical Sensitivity: 100.00 (95% CI 99.63 to 100.00), Exact binomial
HIV-2 Antibody Sensitivity: Clinical Sensitivity: 100.00 (95% CI 98.18 to 100.00), Exact binomial

Population analysed: Sensitivity was determine using confirmed positive specimens/panels for HIV-1 Antigen (63 samples/panels/viral isolates), HIV-1 antibody (1003 US population) and HIV-2 antibody (201 endemic area of Ivory Coast) based on supplemental testing.

Primary outcome: Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population

Time frame: 3 months. Number. Unit: Blood specimens

Measure	Architect HIV Ag/Ab Combo Specificity in Pregnant Females n = 448	Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females n = 65
Architect HIV Ag/Ab Reactive	0	65
Architect HIV Ag/Ab Nonreactive	448	0

Architect HIV Ag/Ab Combo Specificity in Pregnant Females: Clinical Specificity: 100.00 (95% CI 99.18 to 100.00), Exact binomial
Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females: Clinical Sensitivity: 100.00 (95% CI 94.48 to 100.00), Exact binomial

Population analysed: HIV negative status determined for specimens reactive by investigational assay and/or comparator by supplemental testing algorithm including HIV-1 Western blot, HIV-2 enzyme immunoassay (EIA), HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. Specimens from pregnant females.

Primary outcome: Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)

Time frame: 3 months. Number. Unit: Blood specimens

Measure	Architect HIV Ag/Ab Combo Specificity in Pediatric Population n = 588	Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population n = 64
HIV Ag/Ab Combo Reactive HIV Status Positive	0	64
HIV Ag/Ab Combo Reactive HIV Status Negative	1	0
HIV Ag/Ab Combo Nonreactive HIV Status Positive	0	0
HIV Ag/Ab Combo Nonreactive HIV Status Negative	587	0

Architect HIV Ag/Ab Combo Specificity in Pediatric Population: Clinical Specificity: 99.83 (95% CI 99.06 to 100.00), Exact binomial
Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population: Clinical Sensitivity: 100.00 (95% CI 94.40 to 100.00), Exact binomial

Population analysed: Specificity determine from 588 specimens: 364 low risk, 95 increased risk, 47 increased risk (HIV-2 endemic area), 44 pregnant females low risk and 38 pregnant females increased risk with HIV negative status. Sensitivity determined from 65 specimens: 60 HIV-1 infected, 2 HIV-1 infected pregnant females, 2 HIV infected from HIV-2 endemic area.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Device adverse events were collected during the approximate 3 months of testing with Architect HIV Combo assay.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Architect HIV Ag/Ab Combo Specificity	0 of 586 (0%)	0 of 586 (0%)	Not reported
Architect HIV Ag/Ab Combo Sensitivity	0 of 0	0 of 0	Not reported
Architect HIV Ag/Ab Combo Reactivity	0 of 55 (0%)	0 of 55 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Human Immunodeficiency Viruses

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ARCHITECT HIV Ag/Ab Combo in people with Human Immunodeficiency Viruses, run by Abbott Diagnostics Division at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00933933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.