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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Inverness Medical Innovations
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00951795
First received: August 3, 2009
Last updated: June 21, 2011
Last verified: June 2011

August 3, 2009
June 21, 2011
September 2009
September 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00951795 on ClinicalTrials.gov Archive Site
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Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
Clinical Evaluation of the Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

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.

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 fingerstick in duplicate from all Subjects in the study for immediate measurement of CD4+ T-cell count on the Pima CD4 Test by a trained healthcare professional. Venous whole blood samples from all Subjects in the study will also be collected and transported to the clinical laboratory of each study site for concurrent testing on the reference method by a trained laboratory professional. Venous samples from all Subjects in the study will also be measured on the Pima CD4 Test at the study site. Hematocrit will also be measured for all Subjects.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The intended study population is individuals with confirmed diagnosis of HIV infection ≥ 12 years of age presenting to a physician's office or outpatient clinic.

  • HIV Infection
  • AIDS
  • HIV Infections
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  • Adults
    Adult men and women over age of 18
  • Pediatrics
    Pediatric boys and girls ages 12-18
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
240
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 12 years of age or older
  2. 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.
  3. Subject agrees to complete all aspects of the study

Exclusion Criteria:

  1. Subject has already participated in this study at a previous date
  2. Subject is enrolled in a study to evaluate a new drug
  3. Patient unable or unwilling to provide informed consent
  4. Vulnerable populations as deemed inappropriate for study by site principal investigator.
Both
12 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00951795
BSTE-0510
No
Meghan Bigelow (Clinical Trial Manager), Inverness Medical Innovations
Biosite
Inverness Medical Innovations
Not Provided
Biosite
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP