- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951795
Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
July 20, 2015 updated by: Biosite
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.
Study Overview
Status
Withdrawn
Conditions
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
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Fenway Community Health
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Miriam Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Adults
Adult men and women over age of 18
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Pediatrics
Pediatric boys and girls ages 12-18
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
September 1, 2009
Study Completion
September 1, 2009
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimate)
August 4, 2009
Study Record Updates
Last Update Posted (Estimate)
July 21, 2015
Last Update Submitted That Met QC Criteria
July 20, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- BSTE-0510
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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