Expired Study
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Baltimore, Maryland 21201


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

02-HIV02.01


NCT ID:

NCT00567749


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Chembio Diagnostic Systems, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Neil T. Constantine, Ph.D.
Principal Investigator
University of Maryland

Study Dates

Start Date:December 2007
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:June 2008
Last Changed Date:June 25, 2008
First Received Date:December 3, 2007

Study Outcomes

Outcome Type: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:A, Observational

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Chembio Diagnostic Systems, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Inverness Medical Innovations

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Whole blood, plasma and serum
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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