Clinical trial NCT00567749: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV-1 Infections
Lead sponsor: Chembio Diagnostic Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Inverness Medical Innovations
name: University of Maryland
name: Focus Diagnostics, Inc.
First posted: 2007-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
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.
timeFrame: 3-10 days
Secondary outcomes:
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.
timeFrame: 3-10 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Laboratory of Viral Diagnostics, University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Neil T. Constantine, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: