Phase 3
Completed N=8,657
Evaluation of Diagnostic HIV Ag/Ab Combo Assay
Human Immunodeficiency Viruses
Source: ClinicalTrials.gov NCT00933933 ↗
Enrolled (actual)
8,657
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection — 37; 14; 0; 6113 Blood Specimens
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection |
37; 14; 0; 6113 | — |
| PRIMARY Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens |
63; 1003; 201; 0; 0; 0 | — |
| PRIMARY Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population |
0; 65; 448; 0 | — |
| PRIMARY Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) |
0; 64; 1; 0; 0; 0 | — |
| SECONDARY Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations |
65; 83; 5; 6; 6; 0 | — |
Eligibility Criteria
Normal Healthy Population:
Inclusion Criteria
- Apparently healthy individual at the time of enrollment as affirmed by the subject
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00933933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.