Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

Withdrawn before enrolling

Conditions studied: HIV Infection, AIDS, HIV Infections

In brief

This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

Key facts

Study ID

NCT00951795

Run by

Abbott RDx Cardiometabolic

People needed

0

Starts

2009-09-01

Expected to finish

2009-09-01

Last updated by the study team

2015-07-21

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 12 years of age or older
• Confirmed HIV infection, HIV-1 or HIV-2 according to medical history (this inclusion will be waived for healthy non-HIV infected individuals who may need to be enrolled in order to fill the high end of the CD4+ T-cell measurement range of the Pima CD4 Test.
• Subject agrees to complete all aspects of the study

You may not qualify if…

• Subject has already participated in this study at a previous date
• Subject is enrolled in a study to evaluate a new drug
• Patient unable or unwilling to provide informed consent
• Vulnerable populations as deemed inappropriate for study by site principal investigator.

Where it is running

• Fenway Community Health — Boston, Massachusetts, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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