Expired Study
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Baltimore, Maryland 21201


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT00567749


Primary Contact:

Principal Investigator
Neil T. Constantine, Ph.D.
University of Maryland


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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