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

This study has been completed.
Sponsor:
Collaborators:
Inverness Medical Innovations
University of Maryland
Focus Diagnostics, Inc.
Information provided by:
Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00567749
First received: December 3, 2007
Last updated: June 25, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Chembio Diagnostic Systems, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Whole blood, plasma and serum


Enrollment: 10
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A, Observational

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patient population intended for this study (study participants) consists of a minimum of 10 individuals, known to have previously tested positive for HIV antibodies, who are between 12 and 17 years of age. The patients should not be on HAART, however, the sponsor reserves the option to include a limited number of HAART patients for investigational purposes. The number of HAART patients enrolled will depend on the available pediatric HIV positive participant pool. HAART patients will be clearly identified and will be additional to the enrollment needed to meet the study objectives.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567749

Locations
United States, Maryland
Laboratory of Viral Diagnostics, University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Chembio Diagnostic Systems, Inc.
Inverness Medical Innovations
University of Maryland
Focus Diagnostics, Inc.
Investigators
Principal Investigator: Neil T. Constantine, Ph.D. University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Thomas D. Ippolito / VP Regulatory Affairs, Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier: NCT00567749     History of Changes
Other Study ID Numbers: 02-HIV02.01
Study First Received: December 3, 2007
Last Updated: June 25, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Chembio Diagnostic Systems, Inc.:
HIV-1 Infections

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013