At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 24,111 enrolled
Drug / intervention
collection of follow-up sample based on PRISM HIV O Plus resultdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
In Brief
A Phase 3 clinical trial evaluating collection of follow-up sample based on PRISM HIV O Plus result for Healthy Donors and HIV Positive. Completed, enrolled 24,111 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Donors, HIV Positive
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedMay 2008
Primary CompletionAug 2008
TodayJul 2026
First PostedMay 29, 2008
Enrollment StartAug 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.1 years ago
Interventions
collection of follow-up sample based on PRISM HIV O Plus resultdevice
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.