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NCT Number: NCT00933933

Evaluation of Diagnostic HIV Ag/Ab Combo Assay

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.

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Key information

Conditions

Human Immunodeficiency Viruses Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Radiant Research, Phoenix, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARCHITECT HIV Ag/Ab Combo

Device

Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.

Primary outcomes

  1. Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection

    Time frame: 3 months

    HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.

  2. Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens

    Time frame: 3 months

    Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.

  3. Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population

    Time frame: 3 months

    HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.

  4. Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)

    Time frame: 3 months

    HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.

Secondary outcomes

  1. Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations

    Time frame: 3 months

    Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.

Sponsors and collaborators

Lead sponsor

Abbott Diagnostics Division

Industry

Registry information

Official study title

Evaluation of ARCHITECT HIV Ag/Ab Combo Assay

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 7, 2009
Registry last updated
Jul 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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