Evaluation of Diagnostic HIV Ag/Ab Combo Assay

Abbott

Status and phase

Completed

Phase 3

Conditions

Human Immunodeficiency Viruses

Treatments

Device: ARCHITECT HIV Ag/Ab Combo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00933933

7B5-02-06R01

Details and patient eligibility

About

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.

Full description

All specimens collected under separate specimen collection protocols or obtained from specimen suppliers will be provided to the clinical sites performing the investigational HIV test.

This includes 6252 specimens collected from normal healthy individuals (7B5-02-05Z01-01: Collection of Specimens Used in Abbott Laboratories In Vitro Diagnostic HIV and Hepatitis Assays Clinical Studies)and from specimen suppliers. 588 specimens from HIV-infected pediatric subjects and 448 pregnant females at risk for HIV infection collected under protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay)and from specimen suppliers. All specimens were previously collected and frozen, except for a subset of 586 specimens from normal healthy population and 55 specimen from pregnant females at risk for HIV infection which were collected under separate specimen collection protocols and tested as fresh specimens during the study.

In addition, 83 specimens that were HIV antigen positive, 1121 specimens that were HIV-1 antibody positive, 201 specimens that were HIV-2 antibody positive, and 1409 specimens from US at risk for HIV infection or from HIV-2 endemic area were all obtained from specimen suppliers, except for 11 pediatric specimens collected under a separate protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay).

Enrollment

635 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

635 participants in 3 patient groups

ARCHITECT HIV Ag/Ab Combo Specificity

Experimental group

Description:

Specimens collected from normal apparently healthy individuals at low risk for HIV infection will be tested by the investigational HIV test and FDA-licensed HIV test.

Treatment:

Device: ARCHITECT HIV Ag/Ab Combo

ARCHITECT HIV Ag/Ab Combo Sensitivity

No Intervention group

Description:

Specimen with confirmed positive HIV Antigen, HIV-1 antibody, or HIV-2 antibody will be tested by the investigational HIV test.

ARCHITECT HIV Ag/Ab Combo Reactivity

Experimental group

Description:

Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.

Treatment:

Device: ARCHITECT HIV Ag/Ab Combo