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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
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of the DPP HIV Test With Reader and the HIV 1/2 Stat-Pak Test Using Oral Fluids

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity [ Time Frame: 1 to 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Effectiveness of MPC and Chembio Oral Fluid Collection Devices [ Time Frame: 1-3 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

oral fluid samples and venous blood


Enrollment: 101
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A, Observational

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 consists of 100 participants with known (clinically or serologically) confirmed HIV infection. The participants, recruited by the staff of the Laboratory of Vial Diagnostics from the Evelyn Jordan Center, 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

Locations
United States, Maryland
Evelyn Jordan Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Chembio Diagnostic Systems, Inc.
University of Maryland
Investigators
Principal Investigator: Niel Constantine, PhD University of Maryland
  More Information

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

Keywords provided by Chembio Diagnostic Systems, Inc.:
HIV-1 Infections

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on March 14, 2013