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

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ClinicalTrials.gov Identifier: NCT00567749
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : June 27, 2008
Sponsor:
Collaborators:
Inverness Medical Innovations
University of Maryland
Focus Diagnostics, Inc.
Information provided by:
Chembio Diagnostic Systems, Inc.

Study Description
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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.

Condition or disease
HIV Infections

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 Design
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Study Type : Observational
Actual Enrollment : 10 participants
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
Study Start Date : December 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Group/Cohort
A, Observational


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
Whole blood, plasma and serum

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: June 27, 2008
Last Verified: June 2008

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

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