Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
|ClinicalTrials.gov Identifier: NCT00567749|
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : June 27, 2008
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||10 participants|
|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|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567749
|United States, Maryland|
|Laboratory of Viral Diagnostics, University of Maryland School of Medicine|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Neil T. Constantine, Ph.D.||University of Maryland|