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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567749
• Other study ID #: 02-HIV02.01
• Status: Completed
• Phase: N/A
• First received: December 3, 2007
• Last updated: June 25, 2008
• Start date: December 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Chembio Diagnostic Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Laboratory of Viral Diagnostics, University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Chembio Diagnostic Systems, Inc.	Focus Diagnostics, Inc., Inverness Medical Innovations, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No