HIV InfectionNCT00951795
Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
An observational study of HIV Infection and AIDS, run by Abbott RDx Cardiometabolic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, AIDS, HIV Infections
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fenway Community Health
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27514
Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infection, AIDS, HIV Infections
- Keywords
- HIV, AIDS, CD4
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults | Adult men and women over age of 18 | |
| Pediatrics | Pediatric boys and girls ages 12-18 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2009 (estimated)
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Collaborators
- Inverness Medical Innovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951795
- Sponsor's protocol ID
- BSTE-0510
- Status last verified
- Jul 2015
- First submitted
- 3 Aug 2009
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts
- ClinicalTrials.gov ID
- NCT00951795
- Acronym / sponsor ID
- BSTE-0510
- Conditions
- HIV Infection, AIDS, HIV Infections
- Keywords
- HIV, AIDS, CD4
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Collaborators
- Inverness Medical Innovations
- Study start
- Sep 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | –Adult men and women over age of 18 |
| Pediatrics | – | –Pediatric boys and girls ages 12-18 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and AIDS, run by Abbott RDx Cardiometabolic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.