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Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population

This study has been completed.
Study NCT00567749.   Last updated on June 25, 2008.   Information provided by Chembio Diagnostic Systems, Inc.

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Descriptive Information Fields
Brief Title  Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
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
Brief 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.

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 Phase
Study Type  Observational
Study Design  Case-Only, Prospective
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ] [ Designated as safety issue: No ]
Condition  HIV Infections
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  10
Start Date  December 2007
Completion Date June 2008
Eligibility Criteria 

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.
Gender Both
Ages 12 Years to 17 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00567749
Organization ID 02-HIV02.01
Secondary IDs ††
Study Sponsor  Chembio Diagnostic Systems, Inc.
Collaborators †† Inverness Medical Innovations
University of Maryland
Focus Diagnostics, Inc.
Investigators 
Principal Investigator:     Neil T. Constantine, Ph.D.     University of Maryland    
Information Provided By Chembio Diagnostic Systems, Inc.
Verification Date June 2008
First Received Date  December 3, 2007
Last Updated Date June 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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