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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00686205
Other study ID # 7B5-02-05R05
Secondary ID
Status Completed
Phase Phase 3
First received May 21, 2008
Last updated December 16, 2011
Start date August 2007
Est. completion date August 2008

Study information

Verified date December 2011
Source Abbott Diagnostics Division
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 24111
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 17 Years and older
Eligibility Inclusion Criteria:

- Healthy donors that have consented to study

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Device:
collection of follow-up sample based on PRISM HIV O Plus result
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.

Locations

Country Name City State
United States Mississippi Valley Regional Blood Center Davenport Iowa
United States Community Blood Center Dayton Ohio
United States Community Blood Center of Greater Kansas City Kansas City Missouri
United States Interstate Blood Bank, Inc. Memphis Tennessee
United States American Red Cross Philadelphia Pennsylvania
United States Puget Sound Blood Center Renton Washington
United States South Texas Blood And Tissue Center San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Abbott Diagnostics Division

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months No
Primary 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). 12 months No
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