Status:
WITHDRAWN
Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
Lead Sponsor:
Abbott RDx Cardiometabolic
Collaborating Sponsors:
Inverness Medical Innovations
Conditions:
HIV Infection
AIDS
Eligibility:
All Genders
12+ years
Brief Summary
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 Te...
Detailed Description
Blood samples will be collected from HIV infected adolescents and adult men and women presenting to a physician's office or outpatient clinic. Capillary whole blood samples will be obtained by fingers...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00951795
Start Date
September 1 2009
End Date
September 1 2009
Last Update
July 21 2015
Active Locations (3)
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1
Fenway Community Health
Boston, Massachusetts, United States, 02215
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
3
Miriam Hospital
Providence, Rhode Island, United States, 02906