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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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, College Park
Focus Diagnostics, Inc.
Information provided by:
Chembio Diagnostic Systems, Inc.

Tracking Information
First Submitted Date December 3, 2007
First Posted Date December 5, 2007
Last Update Posted Date June 27, 2008
Study Start Date December 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2007)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 4, 2007)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood, plasma and serum
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.
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts A, Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2007)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00567749
Other Study ID Numbers 02-HIV02.01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Thomas D. Ippolito / VP Regulatory Affairs, Chembio Diagnostic Systems, Inc.
Study Sponsor Chembio Diagnostic Systems, Inc.
Collaborators
  • Inverness Medical Innovations
  • University of Maryland, College Park
  • Focus Diagnostics, Inc.
Investigators
Principal Investigator: Neil T. Constantine, Ph.D. University of Maryland, Baltimore
PRS Account Chembio Diagnostic Systems, Inc.
Verification Date June 2008