HIV InfectionsNCT00567749
Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
An observational study of HIV Infections, run by Chembio Diagnostic Systems, Inc. at 1 site in United States.
Trial summary
This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in pediatric subjects who are between 12 and 17 years of age. A minimum of ten (10) known HIV-positive participants will be tested. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- HIV Infections
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2008
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The patient population intended for this study (study participants) consists of a minimum of 10 individuals, known to have previously tested positive for HIV antibodies, who are between 12 and 17 years of age. The patients should not be on HAART, however, the sponsor reserves the option to include a limited number of HAART patients for investigational purposes. The number of HAART patients enrolled will depend on the available pediatric HIV positive participant pool. HAART patients will be clearly identified and will be additional to the enrollment needed to meet the study objectives.
Who may be able to join
- Must be at least 12 years of age and no older than 17 years of age.
- Must be willing to sign (and be given) a copy of the written Information and Assent Form.
- Must have a parent or guardian present to sign and receive a copy of the Informed Consent Form.
- Must be able to provide one or two fingerstick blood samples.
- Must be able to provide three tubes of blood by venipuncture from the arm or hand only.
Who cannot join
- Have a life threatening illness (with the exception of HIV or AIDS).
- Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.), as determined by interviewing the study participant or parent/legal guardian.
- Have participated or are participating in a clinical trial for an HIV vaccine (as determined by interviewing the study participant or parent/legal guardian).
- Have previously participated in this clinical trial (no duplicate enrollments).
- Are currently on HAART, except as agreed on a case-by-case basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Viral Diagnostics, University of Maryland School of Medicine
Baltimore, Maryland, 21201
About this study
Official title: Clinical Sensitivity of the Clearview® COMPLETE HIV 1/2, PMA # BP050009 and the Clearview® HIV 1/2 STAT-PAK®, PMA #BP050010 in the 12 - 17 Year Old Pediatric Population
This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in pediatric subjects who are between 12 and 17 years of age. A minimum of ten (10) known HIV-positive participants will be tested.
Read the detailed description
In order to achieve the primary objective, clinical trials will be conducted to establish and confirm the sensitivity of the Clearview HIV 1/2 tests in the described pediatric population. Only HIV-1 will be included in the study.
The Clearview HIV tests can be used as a safe and effective screening method to aid in the diagnosis of infection with HIV 1/2 in the pediatric population aged between 12 and 17 years.
The secondary objectives of this study include demonstrating that:
- The Clearview HIV tests detect HIV-1 antibodies in a variety of sample matrices: capillary (fingertip) whole blood, venous whole blood, plasma and serum.
- Conditions
- HIV Infections
- Keywords
- HIV-1 Infections
- Medical subject headings
- HIV Infections
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 |
|---|---|---|
| A, Observational | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clearview HIV tests provide a 100% agreement with known HIV(+) status for all 10 eligible 12 to 17 year old individuals, at least one of whom will be age 12.
Measured: 3-10 days
Secondary outcomes (1)
The Clearview tests will be used in a representative clinical setting for the qualitative detection of antibodies to HIV-1 in fingerstick, venous whole blood, serum and plasma matrices.
Measured: 3-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJun 2008
- Study completionJun 2008
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chembio Diagnostic Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inverness Medical Innovations, University of Maryland, Focus Diagnostics, Inc.
- Investigators
- Neil T. Constantine, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567749
- Sponsor's protocol ID
- 02-HIV02.01
- Status last verified
- Jun 2008
- First submitted
- 3 Dec 2007
- Last updated
- 27 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Sensitivity of the Clearview® COMPLETE HIV 1/2, PMA # BP050009 and the Clearview® HIV 1/2 STAT-PAK®, PMA #BP050010 in the 12 - 17 Year Old Pediatric Population
- ClinicalTrials.gov ID
- NCT00567749
- Acronym / sponsor ID
- 02-HIV02.01
- Conditions
- HIV Infections
- Keywords
- HIV-1 Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chembio Diagnostic Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Inverness Medical Innovations, University of Maryland, Focus Diagnostics, Inc.
- Study start
- Dec 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Dec 2007 (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 is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in pediatric subjects who are between 12 and 17 years of age. A minimum of ten (10) known HIV-positive participants will be tested.
Detailed description
In order to achieve the primary objective, clinical trials will be conducted to establish and confirm the sensitivity of the Clearview HIV 1/2 tests in the described pediatric population. Only HIV-1 will be included in the study.
The Clearview HIV tests can be used as a safe and effective screening method to aid in the diagnosis of infection with HIV 1/2 in the pediatric population aged between 12 and 17 years.
The secondary objectives of this study include demonstrating that:
- The Clearview HIV tests detect HIV-1 antibodies in a variety of sample matrices: capillary (fingertip) whole blood, venous whole blood, plasma and serum.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, Observational | – | – |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The patient population intended for this study (study participants) consists of a minimum of 10 individuals, known to have previously tested positive for HIV antibodies, who are between 12 and 17 years of age. The patients should not be on HAART, however, the sponsor reserves the option to include a limited number of HAART patients for investigational purposes. The number of HAART patients enrolled will depend on the available pediatric HIV positive participant pool. HAART patients will be clearly identified and will be additional to the enrollment needed to meet the study objectives.
Key inclusion criteria (5 listed)
- Must be at least 12 years of age and no older than 17 years of age.
- Must be willing to sign (and be given) a copy of the written Information and Assent Form.
- Must have a parent or guardian present to sign and receive a copy of the Informed Consent Form.
- Must be able to provide one or two fingerstick blood samples.
- Must be able to provide three tubes of blood by venipuncture from the arm or hand only.
Key exclusion criteria (5 listed)
- Have a life threatening illness (with the exception of HIV or AIDS).
- Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.), as determined by interviewing the study participant or parent/legal guardian.
- Have participated or are participating in a clinical trial for an HIV vaccine (as determined by interviewing the study participant or parent/legal guardian).
- Have previously participated in this clinical trial (no duplicate enrollments).
- Are currently on HAART, except as agreed on a case-by-case basis.
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
The Clearview HIV tests provide a 100% agreement with known HIV(+) status for all 10 eligible 12 to 17 year old individuals, at least one of whom will be age 12.
Time frame: 3-10 days
1 secondary outcome
The Clearview tests will be used in a representative clinical setting for the qualitative detection of antibodies to HIV-1 in fingerstick, venous whole blood, serum and plasma matrices.
Time frame: 3-10 days
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 27 Jun 2008.
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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.
Neil T. Constantine, Ph.D. principal investigator
University of Maryland, Baltimore
1 site 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 1 site 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 5 inclusion and 5 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 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Clearview HIV tests provide a 100% agreement with known HIV(+) status for all 10 eligible 12 to 17 year old individuals, at least one of whom will be age 12. (time frame: 3-10 days). 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 27 Jun 2008.