HIV InfectionsNCT01032902
Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
An observational study of HIV Infections, run by Chembio Diagnostic Systems, Inc. at 5 sites in United States.
Trial summary
This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- In Vitro Diagnostic Device
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 2,808 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2010to Apr 2012
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Point-of-care test sites including clinics and physician office settings
Who may be able to join
- Must be at least 2 years of age (no upper age limit).
- Must be willing and able to receive post-test counseling, if applicable.
- Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
- Must be able to sustain fingersticks and venipuncture from the arm or hand only.
Who cannot join
- Am in a life threatening condition at the time of enrollment
- Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
- Have participated or are participating in a clinical trial for an HIV vaccine.
- Have previously participated in this clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland
Baltimore, Maryland, 21201-1559
Therafirst
Fort Lauderdale, Florida, 33308
University of Texas HSC
Houston, Texas, 77030
Univeristy of California, San Diego
La Jolla, California, 92093
St. Christopher's Hospital for Children/ Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
About this study
Official title: Study to Establish the Ability of the Chembio Diagnostics Systems, Inc. DPP HIV 1/2 Rapid Test to Qualitatively Detect the Presence of Antibodies Against HIV-1 in Oral Fluid, Whole Blood (Capillary and Venous), Serum and Plasma
This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.
- Conditions
- HIV Infections
- Being tested
- In Vitro Diagnostic Device
- Keywords
- Human immunodeficiency virus, Rapid Test, HIV, HIV Seronegativity
- 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.
In Vitro Diagnostic DeviceDevice
For the detection of antibodies to HIV in serum, plasma, blood and oral fluid
| Study group | Role | What they receive |
|---|---|---|
| Known HIV positive | Patients from HIV clinics with documented infections Receives: Device: In Vitro Diagnostic Device | |
| High Risk for Infection with HIV | Patients from defined HIV high-risk populations - i.e. intravenous drug users, or patients presenting with symptoms of sexually transmitted disease. Receives: Device: In Vitro Diagnostic Device | |
| Low-Risk for Infection with HIV | Individuals not known to belong to any of the defined high-risk groups - i.e. "healthy patients" presenting for routine physicals or other unrelated non-life threatening illnesses, or individuals from a general low risk population such as students, employees of academic or other institutions, etc… Receives: Device: In Vitro Diagnostic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).
Measured: 20 minutes
Secondary outcomes (1)
The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 2,808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chembio Diagnostic Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032902
- Sponsor's protocol ID
- CP-HIV01
- Other IDs
- IDE 14208
- Status last verified
- Apr 2012
- First submitted
- 15 Dec 2009
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Establish the Ability of the Chembio Diagnostics Systems, Inc. DPP HIV 1/2 Rapid Test to Qualitatively Detect the Presence of Antibodies Against HIV-1 in Oral Fluid, Whole Blood (Capillary and Venous), Serum and Plasma
- ClinicalTrials.gov ID
- NCT01032902
- Acronym / sponsor ID
- CP-HIV01
- Conditions
- HIV Infections
- Keywords
- Human immunodeficiency virus, Rapid Test, HIV, HIV Seronegativity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,808 participants (actual)
- Lead sponsor
- Chembio Diagnostic Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Dec 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 study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Known HIV positive | – | Device: In Vitro Diagnostic DevicePatients from HIV clinics with documented infections |
| High Risk for Infection with HIV | – | Device: In Vitro Diagnostic DevicePatients from defined HIV high-risk populations - i.e. intravenous drug users, or patients presenting with symptoms of sexually transmitted disease. |
| Low-Risk for Infection with HIV | – | Device: In Vitro Diagnostic DeviceIndividuals not known to belong to any of the defined high-risk groups - i.e. "healthy patients" presenting for routine physicals or other unrelated non-life threatening illnesses, or individuals from a general low risk population such as students, employees of academic or other institutions, etc… |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Point-of-care test sites including clinics and physician office settings
Key inclusion criteria (4 listed)
- Must be at least 2 years of age (no upper age limit).
- Must be willing and able to receive post-test counseling, if applicable.
- Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
- Must be able to sustain fingersticks and venipuncture from the arm or hand only.
Key exclusion criteria (4 listed)
- Am in a life threatening condition at the time of enrollment
- Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
- Have participated or are participating in a clinical trial for an HIV vaccine.
- Have previously participated in this clinical trial.
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 |
|---|---|---|
| In Vitro Diagnostic DeviceFor the detection of antibodies to HIV in serum, plasma, blood and oral fluid | Device | High Risk for Infection with HIV, Known HIV positive, Low-Risk for Infection with HIV |
Primary outcome
The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).
Time frame: 20 minutes
1 secondary outcome
The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary.
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
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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.
5 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 Infections, run by Chembio Diagnostic Systems, Inc. at 5 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 4 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: finished, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant). (time frame: 20 minutes). 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 30 Apr 2012.