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This study has been withdrawn prior to enrollment.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: July 20, 2015

Last verified: July 2015

History of Changes

Purpose

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
HIV Infection AIDS HIV Infections


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Biosite:


Enrollment:	0
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Adults Adult men and women over age of 18
Pediatrics Pediatric boys and girls ages 12-18

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.

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
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.

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951795

Locations


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

Biosite

Inverness Medical Innovations

More Information


Responsible Party:	Meghan Bigelow (Clinical Trial Manager), Inverness Medical Innovations
ClinicalTrials.gov Identifier:	NCT00951795 History of Changes
Other Study ID Numbers:	BSTE-0510
Study First Received:	August 3, 2009
Last Updated:	July 20, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosite:


HIV AIDS CD4

Additional relevant MeSH terms:


Infection 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

ClinicalTrials.gov processed this record on September 29, 2016

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