Trial Outcomes & Findings for Evaluation of Diagnostic HIV Ag/Ab Combo Assay (NCT NCT00933933)
NCT ID: NCT00933933
Last Updated: 2011-07-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
635 participants
Primary outcome timeframe
3 months
Results posted on
2011-07-12
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.
All subjects were assigned to one group. There was no pre-screening criteria for this study.
Participant milestones
| Measure |
Architect HIV Ag/Ab Combo Specificity
Specificity populations included:
6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy.
448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age.
588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age.
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test.
|
Architect HIV Ag/Ab Combo Sensitivity
Sensitivity populations included:
1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive.
67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing.
64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age).
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test.
|
Architect HIV Ag/Ab Combo Reactivity
Reactivty populations included:
1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire.
203 specimen from pregnant females at risk for HIV infection.
Of these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age.
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test.
|
|---|---|---|---|
|
General Population From 16 to 89 Years
STARTED
|
6164
|
1287
|
1206
|
|
General Population From 16 to 89 Years
COMPLETED
|
6164
|
1267
|
1206
|
|
General Population From 16 to 89 Years
NOT COMPLETED
|
0
|
20
|
0
|
|
Pregnant Females Between 16-44 Years
STARTED
|
448
|
67
|
203
|
|
Pregnant Females Between 16-44 Years
COMPLETED
|
448
|
65
|
203
|
|
Pregnant Females Between 16-44 Years
NOT COMPLETED
|
0
|
2
|
0
|
|
Pediatric From 2 to 21 Years
STARTED
|
588
|
64
|
0
|
|
Pediatric From 2 to 21 Years
COMPLETED
|
588
|
64
|
0
|
|
Pediatric From 2 to 21 Years
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Architect HIV Ag/Ab Combo Specificity
Specificity populations included:
6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy.
448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age.
588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age.
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test.
|
Architect HIV Ag/Ab Combo Sensitivity
Sensitivity populations included:
1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive.
67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing.
64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age).
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test.
|
Architect HIV Ag/Ab Combo Reactivity
Reactivty populations included:
1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire.
203 specimen from pregnant females at risk for HIV infection.
Of these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age.
Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test.
|
|---|---|---|---|
|
General Population From 16 to 89 Years
Did not meet criteria for analysis
|
0
|
20
|
0
|
|
Pregnant Females Between 16-44 Years
Specimens classified incorrectly
|
0
|
2
|
0
|
Baseline Characteristics
Evaluation of Diagnostic HIV Ag/Ab Combo Assay
Baseline characteristics by cohort
| Measure |
Architect HIV Ag/Ab Combo Specificity
n=6252 Participants
Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test.
|
Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity
n=83 Participants
Specimens obtained from specimen vendors were tested with investigational HIV test.
|
Architect Ag/Ab Combo HIV-1 Antibody Sensitivity
n=1121 Participants
Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
|
Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity
n=201 Participants
Specimens obtained from specimen vendors were tested with investigational HIV test.
|
Architect HIV Ag/Ab Combo Reactivity
n=1409 Participants
Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
|
Total
n=9066 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
>= 21 years
|
5663 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1057 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1304 participants
n=21 Participants
|
8024 participants
n=10 Participants
|
|
Age, Customized
Not collected
|
1 participants
n=5 Participants
|
83 participants
n=7 Participants
|
0 participants
n=5 Participants
|
201 participants
n=4 Participants
|
44 participants
n=21 Participants
|
329 participants
n=10 Participants
|
|
Sex/Gender, Customized
Female
|
4165 participants
n=5 Participants
|
0 participants
n=7 Participants
|
231 participants
n=5 Participants
|
0 participants
n=4 Participants
|
530 participants
n=21 Participants
|
4926 participants
n=10 Participants
|
|
Sex/Gender, Customized
Male
|
2087 participants
n=5 Participants
|
0 participants
n=7 Participants
|
890 participants
n=5 Participants
|
0 participants
n=4 Participants
|
879 participants
n=21 Participants
|
3856 participants
n=10 Participants
|
|
Sex/Gender, Customized
Not collected
|
0 participants
n=5 Participants
|
83 participants
n=7 Participants
|
0 participants
n=5 Participants
|
201 participants
n=4 Participants
|
0 participants
n=21 Participants
|
284 participants
n=10 Participants
|
|
Age, Customized
between 2 and 21 years
|
588 participants
n=5 Participants
|
0 participants
n=7 Participants
|
64 participants
n=5 Participants
|
0 participants
n=4 Participants
|
61 participants
n=21 Participants
|
713 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6252 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
1121 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
896 Participants
n=21 Participants
|
8347 Participants
n=10 Participants
|
|
Region of Enrollment
Côte D'Ivoire
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
513 Participants
n=21 Participants
|
714 Participants
n=10 Participants
|
|
Region of Enrollment
South Africa
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Region of Enrollment
Cameroon
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection
n=6164 Participants
Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
|
HIV-1 Antibody Sensitivity
Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
|
HIV-2 Antibody Sensitivity
Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
|
|---|---|---|---|
|
Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
HIV Ag/Ab Combo Reactive, HIV status Positive
|
37 Blood Specimens
Interval 99.62 to 99.88
|
—
|
—
|
|
Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
HIV Ag/Ab Combo Reactive, HIV status Negative
|
14 Blood Specimens
|
—
|
—
|
|
Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
HIV Ag/Ab Combo Nonreactive HIV status Positive
|
0 Blood Specimens
|
—
|
—
|
|
Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
HIV Ag/Ab Combo Nonreactive HIV status Negative
|
6113 Blood Specimens
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection
n=63 Participants
Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
|
HIV-1 Antibody Sensitivity
n=1003 Participants
Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
|
HIV-2 Antibody Sensitivity
n=201 Participants
Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
|
|---|---|---|---|
|
Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens
ARCHITECT HIV Ag/Ab Reactive
|
63 Blood specimens
|
1003 Blood specimens
|
201 Blood specimens
|
|
Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens
ARCHITECT HIV Ag/Ab Nonreactive
|
0 Blood specimens
|
0 Blood specimens
|
0 Blood specimens
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection
n=448 Participants
Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
|
HIV-1 Antibody Sensitivity
n=65 Participants
Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
|
HIV-2 Antibody Sensitivity
Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
|
|---|---|---|---|
|
Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population
Architect HIV Ag/Ab Reactive
|
0 Blood specimens
|
65 Blood specimens
|
—
|
|
Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population
Architect HIV Ag/Ab Nonreactive
|
448 Blood specimens
|
0 Blood specimens
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection
n=588 Participants
Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
|
HIV-1 Antibody Sensitivity
n=64 Participants
Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
|
HIV-2 Antibody Sensitivity
Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
|
|---|---|---|---|
|
Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)
HIV Ag/Ab Combo Reactive HIV Status Positive
|
0 Blood specimens
|
64 Blood specimens
|
—
|
|
Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)
HIV Ag/Ab Combo Reactive HIV Status Negative
|
1 Blood specimens
|
0 Blood specimens
|
—
|
|
Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)
HIV Ag/Ab Combo Nonreactive HIV Status Positive
|
0 Blood specimens
|
0 Blood specimens
|
—
|
|
Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)
HIV Ag/Ab Combo Nonreactive HIV Status Negative
|
587 Blood specimens
|
0 Blood specimens
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Final HIV status determined for specimens reactive by investigational assay and/or comparator by supplement testing algorithm. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot.
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.
Outcome measures
| Measure |
Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection
n=693 Participants
Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
|
HIV-1 Antibody Sensitivity
n=513 Participants
Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
|
HIV-2 Antibody Sensitivity
n=203 Participants
Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
|
|---|---|---|---|
|
Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations
HIV Ag/Ab Combo Reactive HIV Status Positive
|
65 Blood specimens
|
83 Blood specimens
|
5 Blood specimens
|
|
Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations
HIV Ag/Ab Combo Reactive HIV Status Negative
|
6 Blood specimens
|
6 Blood specimens
|
0 Blood specimens
|
|
Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations
HIV Ag/Ab Combo Nonreactive - HIV Status Positive
|
0 Blood specimens
|
0 Blood specimens
|
0 Blood specimens
|
|
Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations
HIV Ag/Ab Combo Nonreactive HIV Status Negative
|
622 Blood specimens
|
424 Blood specimens
|
198 Blood specimens
|
Adverse Events
Architect HIV Ag/Ab Combo Specificity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Architect HIV Ag/Ab Combo Sensitivity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Architect HIV Ag/Ab Combo Reactivity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Barbara Kaesdorf, Associate Director Clinical Affairs
Abbott Diagnostic Division
Phone: 847-937-8702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator (PI) must provide copy of any proposed publication/presentation at least 30 days prior to submission for sponsor review/approval. PI must incorporate changes as the sponosr requires in order to protect the sponsor's proprietary rights and interests. Sponsor may require the PI to include acknowledgement of sponosr's role in the study. PI may be requested to delay publication/presentation an extra 60 days to enable sponor to secure patent or other proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER