Expired Study
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Baltimore, Maryland 21201


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.

Study summary:

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).


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.

Study is Available At:

Original ID:




Secondary ID:

UMB Protocol # H-29110

Study Acronym:


Brief Title:

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

Official Title:

Evaluation of the DPP HIV Test With Reader and the HIV 1/2 Stat-Pak Test Using Oral Fluids

Overall Status:


Study Phase:




Minimum Age:

12 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Chembio Diagnostic Systems, Inc.

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Case-Only, Time Perspective:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Niel Constantine, PhD
Principal Investigator
University of Maryland

Study Dates

Start Date:March 2008
Completion Date:July 2008
Completion Type:Actual
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:December 2009
Last Changed Date:January 20, 2010
First Received Date:March 10, 2008
First Results Date:January 8, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity
Time Frame:1 to 3 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The Effectiveness of MPC and Chembio Oral Fluid Collection Devices
Time Frame:1-3
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:A, Observational

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Chembio Diagnostic Systems, Inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Maryland

Samples and Retentions

Sample Retention:Samples Without DNA
Description: oral fluid samples and venous blood
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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