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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00567749
• Lead Sponsor: Chembio Diagnostic Systems, Inc.

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Status Verified: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2008-06-25
• Last Update Posted: 2008-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	3-10 days

Secondary Outcome Measures

Name	Time	Method
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.	3-10 days

Trial Locations

Locations (1)

Laboratory of Viral Diagnostics, University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States