Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
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ClinicalTrials.gov Identifier: NCT00951795 |
Recruitment Status
:
Withdrawn
First Posted
: August 4, 2009
Last Update Posted
: July 21, 2015
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Condition or disease |
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HIV Infection AIDS HIV Infections |
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 |
Study Completion Date : | September 2009 |

Group/Cohort |
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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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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 |
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.

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 ClinicalTrials.gov 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 |
Responsible Party: | Meghan Bigelow (Clinical Trial Manager), Inverness Medical Innovations |
ClinicalTrials.gov 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:
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 |