Trial Outcomes & Findings for Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay (NCT NCT00686205)
NCT ID: NCT00686205
Last Updated: 2011-12-28
Results Overview
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
COMPLETED
PHASE3
24111 participants
12 months
2011-12-28
Participant Flow
21606 donors enrolled from 6 geographically distinct blood donor and 1 plasmapheresis center. All donors were eligible if they signed a study consent form. In addition, 1388 specimens positive for HIV antibodies and 1117 specimens from US individuals at increased risk of HIV infection or from an HIV-2 endemic area.
All subjects were assigned to one group. There was no pre-screening criteria specific for this study.
Participant milestones
| Measure |
ABBOTT PRISM® HIV O Plus Assay Results for Specificity
Blood specimens collected from donors were tested by the investigational HIV test.
|
ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
|
|---|---|---|
|
Overall Study
STARTED
|
21606
|
2505
|
|
Overall Study
COMPLETED
|
15599
|
1524
|
|
Overall Study
NOT COMPLETED
|
6007
|
981
|
Reasons for withdrawal
| Measure |
ABBOTT PRISM® HIV O Plus Assay Results for Specificity
Blood specimens collected from donors were tested by the investigational HIV test.
|
ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
127
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Specimen handling procedure altered
|
5878
|
0
|
|
Overall Study
Specimens not confirmed HIV positive
|
0
|
981
|
Baseline Characteristics
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
Baseline characteristics by cohort
| Measure |
ABBOTT PRISM® HIV O Plus Assay Results for Specificity
n=21606 Participants
Blood specimens collected from donors were tested by the investigational HIV test.
|
ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity
n=2505 Participants
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
|
Total
n=24111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>= 17 years
|
21606 Participants
n=93 Participants
|
2454 Participants
n=4 Participants
|
24060 Participants
n=27 Participants
|
|
Age, Customized
not collected
|
0 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=93 Participants
|
1683 Participants
n=4 Participants
|
1683 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=93 Participants
|
441 Participants
n=4 Participants
|
441 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Not Collected
|
21606 Participants
n=93 Participants
|
381 Participants
n=4 Participants
|
21987 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
21606 participants
n=93 Participants
|
1614 participants
n=4 Participants
|
23220 participants
n=27 Participants
|
|
Region of Enrollment
Côte D'Ivoire
|
0 participants
n=93 Participants
|
840 participants
n=4 Participants
|
840 participants
n=27 Participants
|
|
Region of Enrollment
Cameroon
|
0 participants
n=93 Participants
|
51 participants
n=4 Participants
|
51 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis was per the protocol.
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
Outcome measures
| Measure |
HIV Negative Donors
n=15599 Participants
Donors with HIV-1/2 negative results using reference test and negative by HIV-1 RNA test
|
|---|---|
|
PRISM HIV O Plus Test Data for Specificity
PRISM HIV O Plus reactive
|
10 participants
|
|
PRISM HIV O Plus Test Data for Specificity
PRISM HIV O Plus nonreactive
|
15589 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 1,388 specimens from individuals positive for HIV antibodies and 136 specimens positive by supplemental testing from US individuals at increased risk of HIV infection or from an HIV-2 endemic area. These 1,524 specimens were used for the sensitivity calculation.
Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).
Outcome measures
| Measure |
HIV Negative Donors
n=1524 Participants
Donors with HIV-1/2 negative results using reference test and negative by HIV-1 RNA test
|
|---|---|
|
PRISM HIV O Plus Test Data for Sensitivity
PRISM HIV O Plus nonreactive
|
0 participants
|
|
PRISM HIV O Plus Test Data for Sensitivity
PRISM HIV O Plus reactive
|
1524 participants
|
Adverse Events
ABBOTT PRISM® HIV O Plus Assay Results for Specificity
ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI must provide a copy of any proposed publication or presentation at least 30 days prior to submission for sponsor's review/approval. The PI must incorporate changes as the sponsor requires in order to protect the sponsor's proprietary rights and interests. The sponsor may require the PI to include acknowledgement of the sponsor's role in the study. The PI may be requested to delay publication/presentation an extra 60 days to enable sponsor to secure patent or other proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER