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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV-1 Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A, Observational

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Chembio Diagnostic Systems, Inc.

Principal Investigators

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Neil T. Constantine, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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Laboratory of Viral Diagnostics, University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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02-HIV02.01

Identifier Type: -

Identifier Source: org_study_id