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

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00567749

Run by

Chembio Diagnostic Systems, Inc.

People needed

10

Starts

2007-12-01

Expected to finish

2008-06-01

Last updated by the study team

2008-06-27

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Laboratory of Viral Diagnostics, University of Maryland School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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