Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid (HIVOF)

This study has been completed.

Sponsor:

Collaborator:

University of Maryland

Information provided by:

Chembio Diagnostic Systems, Inc.

ClinicalTrials.gov Identifier:

NCT00636220

First received: March 10, 2008

Last updated: January 20, 2010

Last verified: December 2009

History of Changes

Results First Received: January 8, 2009

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Cross-Sectional
Condition:	HIV Infections

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Confirmed HIV Infection	participants with known (clinically or serologically) confirmed HIV infection.

Baseline Measures

	Confirmed HIV Infection
Number of Participants [units: participants]	101
Age [units: participants]
<=18 years	0
Between 18 and 65 years	101
>=65 years	0
Age [units: years] Mean ± Standard Deviation	46 ± 7.1
Gender [units: participants]
Female	41
Male	60
Region of Enrollment [units: participants]
United States	101
Fresh Oral Fluid Samples with known HIV reactivity ^[1] [units: samples]	101
Participants with known HIV reactivity ^[2] [units: Participants]	101

[1]	Fresh Oral Fluid samples were collected from participants with known HIV+ status. HIV reactivity was clinically or serologically confirmed.
[2]	participants with known HIV reactivity

Outcome Measures

1. Primary:

Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity [ Time Frame: 1 to 3 days ]

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2. Secondary:

The Effectiveness of MPC and Chembio Oral Fluid Collection Devices [ Time Frame: 1-3 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Javan Esfandiari
Organization: Chembio Diagnostic Systems, Inc.
phone: (631) 924-1135 ext 112
e-mail: jesfandiari@chembio.com

No publications provided

Responsible Party:	Thomas D. Ippolito, Chembio Diagnostic Systems, Inc
ClinicalTrials.gov Identifier:	NCT00636220 History of Changes
Other Study ID Numbers:	P-HIV-01, UMB Protocol # H-29110
Study First Received:	March 10, 2008
Results First Received:	January 8, 2009
Last Updated:	January 20, 2010
Health Authority:	United States: Institutional Review Board

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