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

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ClinicalTrials.gov Identifier: NCT00636220
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : February 15, 2010
Last Update Posted : August 17, 2015
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Chembio Diagnostic Systems, Inc.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition HIV Infections
Enrollment 101

Recruitment Details Recruitment time period was from March 13, 2008 to July 1, 2008. All enrollment was at the Evelyn Jordan Center, University of Maryland Baltimore (UMD).
Pre-assignment Details  
Arm/Group Title Confirmed HIV Infection
Hide Arm/Group Description The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
Period Title: Overall Study
Started 101
Completed 101
Not Completed 0
Arm/Group Title Confirmed HIV Infection
Hide Arm/Group Description participants with known (clinically or serologically) confirmed HIV infection.
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
<=18 years
0
   0.0%
Between 18 and 65 years
101
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
46  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
41
  40.6%
Male
60
  59.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 101 participants
101
Fresh Oral Fluid Samples with known HIV reactivity   [1] 
Measure Type: Number
Unit of measure:  Samples
Number Analyzed 101 participants
101
[1]
Measure Description: Fresh Oral Fluid samples were collected from participants with known HIV+ status. HIV reactivity was clinically or serologically confirmed.
Participants with known HIV reactivity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
101
[1]
Measure Description: participants with known HIV reactivity
1.Primary Outcome
Title Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity
Hide Description Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.
Time Frame 1 to 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Confirmed HIV Infection
Hide Arm/Group Description:
The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: samples
100
2.Secondary Outcome
Title The Effectiveness of MPC and Chembio Oral Fluid Collection Devices
Hide Description [Not Specified]
Time Frame 1-3
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Confirmed HIV Infection
Hide Arm/Group Description The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
All-Cause Mortality
Confirmed HIV Infection
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Confirmed HIV Infection
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Confirmed HIV Infection
Affected / at Risk (%)
Total   0/0 
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.
Results Point of Contact
Name/Title: Javan Esfandiari
Organization: Chembio Diagnostic Systems, Inc.
Phone: (631) 924-1135 ext 112
Responsible Party: Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier: NCT00636220     History of Changes
Other Study ID Numbers: P-HIV-01
UMB Protocol # H-29110
First Submitted: March 10, 2008
First Posted: March 14, 2008
Results First Submitted: January 8, 2009
Results First Posted: February 15, 2010
Last Update Posted: August 17, 2015