- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00567749
Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- Laboratory of Viral Diagnostics, University of Maryland School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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A, Observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3-10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3-10 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neil T. Constantine, Ph.D., University of Maryland, Baltimore
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-HIV02.01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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