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

Tracking Information

First Received Date ^ICMJE

December 3, 2007

Last Updated Date

June 25, 2008

Start Date ^ICMJE

December 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00567749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00567749

Responsible Party

Thomas D. Ippolito / VP Regulatory Affairs, Chembio Diagnostic Systems, Inc.

Study ID Numbers ^ICMJE

02-HIV02.01

Study Sponsor ^ICMJE

Chembio Diagnostic Systems, Inc.

Collaborators ^ICMJE

Inverness Medical Innovations
University of Maryland
Focus Diagnostics, Inc.

Investigators ^ICMJE

Principal Investigator:

Neil T. Constantine, Ph.D.

University of Maryland

Information Provided By

Chembio Diagnostic Systems, Inc.

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP