HIV Positive Clinical Trial
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 |
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.
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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 |
Lead Sponsor | Collaborator |
---|---|
Abbott Diagnostics Division |
United States,
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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