Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay

HIV Positive Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686205
• Other study ID #: 7B5-02-05R05
• 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

• Acquired Immunodeficiency Syndrome
• Healthy Donors
• HIV Infections
• HIV Positive
• HIV Seropositivity

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