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

NCT00567749 | Completed DMC

• 1 other identifier: 02-HIV02.01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV-1 Infections

Outcome Measures

Primary Outcomes (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.

  3-10 days

Secondary Outcomes (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.

  3-10 days

Study Arms (1)

A, Observational

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chembio Diagnostic Systems, Inc.: lead
• Inverness Medical Innovations: collaborator
• University of Maryland: collaborator
• Focus Diagnostics, Inc.: collaborator

Study Sites (1)

Laboratory of Viral Diagnostics, University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma and serum

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Neil T. Constantine, Ph.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: December 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 27, 2008

Record last verified: 2008-06

Locations

US (1)