Evaluation of Diagnostic HIV Ag/Ab Combo Assay
Completed · Phase 3
Conditions studied: Human Immunodeficiency Viruses
In brief
To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.
Key facts
- Study ID
- NCT00933933
- Run by
- Abbott Diagnostics Division
- People needed
- 635
- Starts
- 2009-06-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2011-07-12
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Apparently healthy individual at the time of enrollment as affirmed by the subject
You may not qualify if…
- HIV infection as affirmed by the subject
- Pregnant Female Population at Risk for HIV Infection:
- Inclusion Criteria:
- Subject is a pregnant female
- Subject has risk factor for HIV infection
- Exclusion Criteria:
- HIV infection as affirmed by the subject
- HIV-1 Positive Pregnant Female Subjects
- Inclusion Criteria:
- Subject is a pregnant female in first, second, or third trimester
- Subject must have documented HIV infection
- Exclusion Criteria:
- None
- HIV-1 Positive Pediatric Subjects
- Inclusion Criteria:
- Subject must be 2 years to 16 years of age
- Subject must have documented HIV infection (e.g., Western blot positive or HIV RNA positive/detectable)
- Exclusion Criteria:
- None
Where it is running
- Radiant Research — Phoenix, Arizona, United States
- Pinellas County Health Dept, Florida Department of Health — St. Petersburg, Florida, United States
- Springfield Clinic, LLP — Springfield, Illinois, United States
- Minneapolis Medical Research Foundation — Minneapolis, Minnesota, United States
- John T. Mather Memorial Hospital — Port Jefferson, New York, United States
- Jacobi Medical Center — The Bronx, New York, United States
- M.S. Hershey Medical Center — Hershey, Pennsylvania, United States
- University of Texas Medical Branch at Galveston — Galveston, Texas, United States
- University of Texas Medical Branch — Galveston, Texas, United States
- Planned Parenthood of Houston and Southeast Texas, Inc. — Houston, Texas, United States
- ARUP Laboratories — Salt Lake City, Utah, United States
- Midwest Research Specialists, LLC — Milwaukee, Wisconsin, United States
- Clement J. Zablocki VA Medical Center — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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