A Phase 3 interventional study of collection of follow-up sample based on PRISM HIV O Plus result in Healthy Donors and HIV Positive, sponsored by Abbott Diagnostics Division. Completed at 7 sites in United States. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-28.
Sponsored by Abbott Diagnostics Division (part of Abbott) · Phase 3, Interventional, and Screening
To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.
194 studies on the registry are indexed under HIV Seropositivity; 11 are open to participants now.
This study's enrollment of 24,111 is above the median of 105 across 114 interventional studies indexed under HIV Seropositivity.
Browse HIV Seropositivity studies →Abbott Diagnostics Division is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Inclusion Criteria:
All subjects will have their blood tested by the investigational HIV test.
Device: collection of follow-up sample based on PRISM HIV O Plus result
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.
PRISM HIV O Plus Test Data for Specificity
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
Time frame: 12 months
PRISM HIV O Plus Test Data for Sensitivity
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).
Time frame: 12 months
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.
| Milestone | ABBOTT PRISM® HIV O Plus Assay Results for Specificity | ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity |
|---|---|---|
| Started | 21606 | 2505 |
| Completed | 15599 | 1524 |
| Not completed | 6007 | 981 |
| Withdrew: Protocol violation | 127 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Specimen handling procedure altered | 5878 | 0 |
| Withdrew: Specimens not confirmed hiv positive | 0 | 981 |
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
| participants | HIV Negative Donors |
|---|---|
| PRISM HIV O Plus reactive | 10 |
| PRISM HIV O Plus nonreactive | 15589 |
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).
| participants | HIV Positive Samples |
|---|---|
| PRISM HIV O Plus reactive | 1524 |
| PRISM HIV O Plus nonreactive | 0 |
Collected over Subject related adverse events related to blood collection of the 19 follow-up specimens - 8/23/07 to 8/12/08.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABBOTT PRISM® HIV O Plus Assay Results for Specificity | — | 0/19 (0%) | 0/19 (0%) |
| ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity | — | — | — |
| Age, Customized(Participants) | ABBOTT PRISM® HIV O Plus Assay Results for Specificity | ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity | Total |
|---|---|---|---|
| >= 17 years | 21606 | 2454 | 24060 |
| not collected | 0 | 51 | 51 |
| Sex/Gender, Customized(Participants) | ABBOTT PRISM® HIV O Plus Assay Results for Specificity | ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity | Total |
|---|---|---|---|
| Male | 0 | 1683 | 1683 |
| Female | 0 | 441 | 441 |
| Not Collected | 21606 | 381 | 21987 |
| Region of Enrollment(participants) | ABBOTT PRISM® HIV O Plus Assay Results for Specificity | ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity | Total |
|---|---|---|---|
| United States | 21606 | 1614 | 23220 |
| Côte D'Ivoire | 0 | 840 | 840 |
| Cameroon | 0 | 51 | 51 |
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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