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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00951795
Recruitment Status : Withdrawn
First Posted : August 4, 2009
Last Update Posted : July 21, 2015
Inverness Medical Innovations
Information provided by:

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 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.

Condition or disease
HIV Infection AIDS HIV Infections

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 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.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of the Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
Study Start Date : September 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Adult men and women over age of 18
Pediatric boys and girls ages 12-18

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00951795

United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02215
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Inverness Medical Innovations

Responsible Party: Meghan Bigelow (Clinical Trial Manager), Inverness Medical Innovations Identifier: NCT00951795     History of Changes
Other Study ID Numbers: BSTE-0510
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Biosite:

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases