Trial record 15 of 43 for:
" May 21, 2008":" June 20, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
This study has been completed.
Sponsor:
Abbott Diagnostics Division
Information provided by (Responsible Party):
Abbott Diagnostics Division
ClinicalTrials.gov Identifier:
NCT00686205
First received: May 21, 2008
Last updated: December 16, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Donors HIV Positive |
Device: collection of follow-up sample based on PRISM HIV O Plus result |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Abbott Diagnostics Division:
Primary Outcome Measures:
- PRISM HIV O Plus Test Data for Specificity [ Time Frame: 12 months ] [ Designated as safety issue: No ]Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
- PRISM HIV O Plus Test Data for Sensitivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]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).
| Enrollment: | 24111 |
| Study Start Date: | August 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ABBOTT PRISM HIV O Plus assay for Specificity
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
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.
|
|
No Intervention: ABBOTT PRISM HIV O Plus Assay for Sensitivity
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
|
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy donors that have consented to study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686205
Locations
| United States, Iowa | |
| Mississippi Valley Regional Blood Center | |
| Davenport, Iowa, United States, 52807 | |
| United States, Missouri | |
| Community Blood Center of Greater Kansas City | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Ohio | |
| Community Blood Center | |
| Dayton, Ohio, United States, 45402 | |
| United States, Pennsylvania | |
| American Red Cross | |
| Philadelphia, Pennsylvania, United States, 19123 | |
| United States, Tennessee | |
| Interstate Blood Bank, Inc. | |
| Memphis, Tennessee, United States, 38134 | |
| United States, Texas | |
| South Texas Blood And Tissue Center | |
| San Antonio, Texas, United States, 78201 | |
| United States, Washington | |
| Puget Sound Blood Center | |
| Renton, Washington, United States, 98057 | |
Sponsors and Collaborators
Abbott Diagnostics Division
More Information
No publications provided
| Responsible Party: | Abbott Diagnostics Division |
| ClinicalTrials.gov Identifier: | NCT00686205 History of Changes |
| Other Study ID Numbers: | 7B5-02-05R05 |
| Study First Received: | May 21, 2008 |
| Results First Received: | January 13, 2010 |
| Last Updated: | December 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott Diagnostics Division:
|
healthy donors HIV positives |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013