Trial Outcomes & Findings for Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid (NCT NCT00636220)

Last Updated: 2015-08-17

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

101 participants

Primary outcome timeframe

1 to 3 days

Results posted on

2015-08-17

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Confirmed HIV Infection The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
Overall Study STARTED	101
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Confirmed HIV Infection n=101 Participants participants with known (clinically or serologically) confirmed HIV infection.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants
Fresh Oral Fluid Samples with known HIV reactivity	101 samples n=5 Participants
Participants with known HIV reactivity	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 to 3 days

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.

Outcome measures

Outcome measures
Measure	Confirmed HIV Infection n=100 Participants The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity	100 samples

SECONDARY outcome

Timeframe: 1-3

Outcome measures

Outcome data not reported

Adverse Events

Confirmed HIV Infection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Javan Esfandiari

Chembio Diagnostic Systems, Inc.

Phone: (631) 924-1135

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place