Clinical trial NCT00933933: Evaluation of Diagnostic HIV Ag/Ab Combo Assay
Official title: Evaluation of ARCHITECT HIV Ag/Ab Combo Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Immunodeficiency Viruses
Lead sponsor: Abbott Diagnostics Division
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 635
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
timeFrame: 3 months
measure: Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens
timeFrame: 3 months
measure: Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population
timeFrame: 3 months
measure: Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)
timeFrame: 3 months
Secondary outcomes:
measure: Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations
timeFrame: 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Radiant Research
state: Arizona
city: St. Petersburg
country: United States
facility: Pinellas County Health Dept, Florida Department of Health
state: Florida
city: Springfield
country: United States
facility: Springfield Clinic, LLP
state: Illinois
city: Minneapolis
country: United States
facility: Minneapolis Medical Research Foundation
state: Minnesota
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Port Jefferson
country: United States
facility: John T. Mather Memorial Hospital
state: New York
city: Hershey
country: United States
facility: M.S. Hershey Medical Center
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Planned Parenthood of Houston and Southeast Texas, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: ARUP Laboratories
state: Utah
city: Milwaukee
country: United States
facility: Midwest Research Specialists, LLC
state: Wisconsin
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center
state: Wisconsin
Study officials:
affiliation: ARUP Laboratories
name: William Roberts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.S. Hershey Medical Center
name: Laurence Demers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hennepin Healthcare Research Institute
name: Fred Apple, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical Branch at Galveston
name: Michael Loeffelholz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clement J. Zablocki VA Medical Center
name: John Heffner
role: PRINCIPAL_INVESTIGATOR
References: