Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid - Full Text View

Sponsors and Collaborators:	Chembio Diagnostic Systems, Inc. University of Maryland
Information provided by:	Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier:	NCT00636220

Purpose

This protocol is intended to test the feasibility of using the HIV 1/2 STAT-PAK and the DPP HIV 1/2 test (with and without the DPP Handheld Reader) to detect HIV antibodies in oral fluids.

Condition
HIV Infections

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective
Official Title:	Evaluation of the DPP HIV Test With Reader and the HIV 1/2 Stat-Pak Test Using Oral Fluids

Further study details as provided by Chembio Diagnostic Systems, Inc.:

Primary Outcome Measures:

The DPP HIV test and HIV Stat Pak tests will provide a 100% agreement with known HIV(+) status using fresh oral fluid samples [ Time Frame: 1 to 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the effectiveness of MPC and Chembio Oral Fluid collection devices [ Time Frame: 1-3 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

The remaining oral fluid samples and venous blood will be stored on ice (or between 2 oC and 8 oC) and shipped on ice to Chembio within 48 hours of collection. Additional testing with FDA-approved screening and confirmatory tests may be performed by Chembio.

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
A, Observational The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.

Detailed Description:

The objective of this study is to evaluate the feasibility of using fresh oral fluid specimens, from known HIV-positive individuals, to test for HIV-1 antibodies using both the DPP HIV 1/2 and HIV 1/2 STAT-PAK tests. Two oral fluid collection devices will be used and compared (MPC and Chembio collection devices) and the results obtained from oral fluids will be compared with those obtained from whole blood and plasma using paired samples from the same participants. The comparison between oral fluid, whole blood and plasma will be made in both Chembio devices (HIV 1/2 STAT-PAK and DPP HIV 1/2).

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection. The participants will be recruited by the staff of the Laboratory of Vial Diagnostics from the Evelyn Jordan Center. Participants may be males or females (including pregnant women) at least 12 years of age from any ethnic and racial background.

Criteria

Inclusion Criteria:

Participants with known HIV infection who are willing to participate in the study and who sign an informed consent (or assent), will be included in the study.
Patients on HAART treatment for HIV will be included, but this information as well as the dates (duration) of treatment will be obtained through the interview of study participants; a medical record review is not necessary or required. The study participant's responses will be recorded by study staff on a Data Collection Form.
Patients with immunosuppressive conditions other than HIV will be included if available, but will be limited to < 25% of the total test population. Immunosuppression will also be assessed through interview of study participants and/or through verbal confirmation by the treating physician; a medical record/chart review is not required.
Patients must be willing to undergo venipuncture to donate one tube of EDTA whole blood (not more than 10cc), and to provide three oral fluid samples.

Exclusion Criteria:

Patients who do not consent, withdraw consent, or for whom the investigator determines that venipuncture or gum swabbing may create a health risk will be excluded from the study.
Participants who have been enrolled in HIV vaccine studies will be excluded from the study. This will be ascertained through interview of study participants.
Participants who have been enrolled once in this study will be excluded from repeat enrollment.
Participants must not have introduced any substance into their oral cavity (gum, food, beverage, candy, lozenges, mouthwash, etc.) for 30 minutes prior to providing an oral fluid sample. This will be ascertained through interview of study participants.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636220

Contacts

Contact: Javan Esfandiari

631-924-1135

jesfandari@chembio.com

Locations

United States, Maryland
Evelyn Jordan Center, University of Maryland	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Neil Constantine 410-706-2788 constant@umbi.umd.edu
Contact: Fassil Ketema (410) 706-2214 fketema@ihv.umaryland.edu

Sponsors and Collaborators

Chembio Diagnostic Systems, Inc.

University of Maryland

Investigators

Principal Investigator:

Niel Constantine, PhD

University of Maryland School of Medicine

More Information

No publications provided

Responsible Party:	Chembio Diagnostic Systems, Inc ( Thomas D. Ippolito )
Study ID Numbers:	P-HIV-01, UMB Protocol # H-29110
Study First Received:	March 10, 2008
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00636220 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Chembio Diagnostic Systems, Inc.:

HIV-1 Infections

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Antibodies
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009