Healthy DonorsPhase 3NCT00686205
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
A Phase 3 study testing collection of follow-up sample based on PRISM HIV O Plus result in people with Healthy Donors and HIV Positive, run by Abbott Diagnostics Division at 7 sites in United States.
Trial summary
To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Donors, HIV Positive
- What is being tested?
- collection of follow-up sample based on PRISM HIV O Plus result
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24,111 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2007to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy donors that have consented to study
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Mississippi Valley Regional Blood Center
Davenport, Iowa, 52807
Community Blood Center
Dayton, Ohio, 45402
Community Blood Center of Greater Kansas City
Kansas City, Missouri, 64111
Interstate Blood Bank, Inc.
Memphis, Tennessee, 38134
American Red Cross
Philadelphia, Pennsylvania, 19123
Puget Sound Blood Center
Renton, Washington, 98057
South Texas Blood And Tissue Center
San Antonio, Texas, 78201
About this study
To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.
- Conditions
- Healthy Donors, HIV Positive
- Being tested
- collection of follow-up sample based on PRISM HIV O Plus result
- Keywords
- healthy donors, HIV positives
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of follow-up sample based on PRISM HIV O Plus resultDevice
Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.
| Study group | Role | What they receive |
|---|---|---|
| ABBOTT PRISM HIV O Plus assay for Specificity | Experimental | All subjects will have their blood tested by the investigational HIV test. Receives: Device: collection of follow-up sample based on PRISM HIV O Plus result |
| ABBOTT PRISM HIV O Plus Assay for Sensitivity | No intervention | Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRISM HIV O Plus Test Data for Specificity
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
Measured: 12 months
PRISM HIV O Plus Test Data for Sensitivity
Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy DonorsStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diagnostics Division
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686205
- Sponsor's protocol ID
- 7B5-02-05R05
- Status last verified
- Dec 2011
- First submitted
- 21 May 2008
- Last updated
- 28 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
- ClinicalTrials.gov ID
- NCT00686205
- Acronym / sponsor ID
- 7B5-02-05R05
- Conditions
- Healthy Donors, HIV Positive
- Keywords
- healthy donors, HIV positives
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24,111 participants (actual)
- Lead sponsor
- Abbott Diagnostics DivisionIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Posted 5 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABBOTT PRISM HIV O Plus assay for Specificity | Experimental | Device: collection of follow-up sample based on PRISM HIV O Plus resultAll subjects will have their blood tested by the investigational HIV test. |
| ABBOTT PRISM HIV O Plus Assay for Sensitivity | No intervention | –Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy donors that have consented to study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of follow-up sample based on PRISM HIV O Plus resultTest blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw. | Device | ABBOTT PRISM HIV O Plus assay for Specificity |
Primary outcome
PRISM HIV O Plus Test Data for Specificity
Time frame: 12 months
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
PRISM HIV O Plus Test Data for Sensitivity
Time frame: 12 months
Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing collection of follow-up sample based on PRISM HIV O Plus result in people with Healthy Donors and HIV Positive, run by Abbott Diagnostics Division at 7 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 28 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
PRISM HIV O Plus Test Data for Specificity (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 28 Dec 2011.