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

Sponsor:	Biosite
Collaborator:	Inverness Medical Innovations
Information provided by:	Biosite
ClinicalTrials.gov Identifier:	NCT00951795

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Potassium iodide

U.S. FDA Resources

Further study details as provided by Biosite:

Estimated Enrollment:	240
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
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

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

No publications provided

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:	June 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosite:

HIV
AIDS
CD4

Additional relevant MeSH terms:

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 February 09, 2012