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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

December 3, 2007
June 25, 2008
December 2007
June 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00567749 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood, plasma and serum

Non-Probability Sample

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.

HIV Infections
Not Provided
A, Observational
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567749
02-HIV02.01
Yes
Thomas D. Ippolito / VP Regulatory Affairs, Chembio Diagnostic Systems, Inc.
Chembio Diagnostic Systems, Inc.
  • Inverness Medical Innovations
  • University of Maryland
  • Focus Diagnostics, Inc.
Principal Investigator: Neil T. Constantine, Ph.D. University of Maryland, Baltimore County
Chembio Diagnostic Systems, Inc.
June 2008

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