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VioOne HIV Profile Supplemental Assay

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ClinicalTrials.gov Identifier: NCT03727932
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Clinical Reference Laboratory
Duke Clinical Research Institute
University of North Carolina
Information provided by (Responsible Party):
Avioq, Inc.

Brief Summary:
Assessment of the sensitivity, specificity and reproducibility of the VioOne HIV Profile Supplemental Assay

Condition or disease Intervention/treatment Phase
HIV Infections Device: VioOne HIV Profile Supplemental Assay Not Applicable

Detailed Description:

Specificity A total of 280 serum samples and 300 plasma samples from a low-risk population (e.g. blood donors) will be collected at Houston Gulf Coast Regional Blood Center (Houston, TX). All serum and plasma specimens will be previously screened and found non-reactive with FDA licensed or approved HIV-1/2 assays (a population of samples that would not normally be tested with the Avioq VioOne™ HIV Profile™ Supplemental Assay). The number of serum samples will be supplemented up to 300 with the inclusion of 20 pediatric samples; 10 from children aged 2 - 11 and 10 from children aged 12-18 for a total of 600 samples for specificity testing. Samples will be tested with one of three validation kit lots of the Avioq VioOne TM HIV Profile™ Supplemental Assay manufactured at Avioq.

The samples will be tested at 3 external sites in proportions based on the manufacturing size of the individual validation lots. At Site 1 the samples will be further divided approximately 70% I 30% between Validation lots 1 & 2. At Site 2 the samples will be divided approximately 70% / 30%, between Validation lots 2 and 3. At site 3 the samples will be tested entirely with Validation lot 3. The study design calls for the use of at least one lot in common at all 3 clinical sites based on a request from the FDA.

For the Specificity Study, any indeterminate or reactive samples will be tested with either the FDA approved Bio-Rad Geenius assay or Western Blot to determine the true classification. Specificity and 95% confidence intervals will be calculated.

Sensitivity Serum or plasma (n= 757) repository samples from individuals infected with HIV will be tested at four external sites and at Avioq with up to four validation kit lots. The samples will be tested at all sites in proportions based on the manufacturing size of the individual validation lots. At Site 1 the samples will be further divided approximately 75% I 25% between Validation lots 1 & 2. At Site 2 the samples will be divided approximately 75% / 25%, between Validation lots 2 and 3. At sites 3 and 4 the samples will be tested entirely with Validation lot 3. A fourth lot (Validation lot 5) will be used to test a few HIV-1 Group O samples at Avioq. The study design calls for the use of at least one lot in common at all 4 clinical sites based on a request from the FDA.

The sensitivity samples will consist of 400 HIV positives, a minimum of 200 HIV-2 positives, 50 AIDS positive, 40 pediatric HIV positive, a minimum of 15 HIV-O positives, 10 HIV-1/HIV-2 coinfected positives and a minimum of 27 samples from pregnant females (samples from all three trimesters) infected with HIV.

All specimens are expected to be positive for HIV-1 and/or HIV-2 antibody representing the types of specimens expected to be tested with the Avioq VioOne™ HIV Profile™ Supplemental Assay. Samples with VioOne™ HIV Profile™ assay results discordant from this expectation will be resolved by testing the same samples in FDA approved confirmatory assays such as the BioRad Geenius or Western Blot.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 757 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: VioOne™ HIV Profile™ Supplemental Assay
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : April 11, 2018
Actual Study Completion Date : April 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
VioOne HIV Profile
HIV Profile™ is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. It is intended as an additional, more specific test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens repeatedly reactive in diagnosis or screening procedures, including pediatric patients (ages 2-20).
Device: VioOne HIV Profile Supplemental Assay
The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of Human Immunodeficiency Virus Type 1 (HIV-1 Group M & Group O) and Type 2 (HIV-2) in human serum or plasma. The HIV Profile™ is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2.




Primary Outcome Measures :
  1. Clinical specificity and sensitivity of HIV Infection [ Time Frame: 9 months ]
    Clinical Specificity and 95% CI of the Profile Assay Clinical Sensitivity and 95% CI of the Profile Assay



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Specificity = 280 Serum Samples and 300 Plasma Samples
  • An additional 20 Serum pediatric samples
  • From low risk population (e.g. blood donors)
  • Sensitivity = 757 Total Samples

    • 400 HIV positive,
    • 200 HIV-2 positive
    • 50 AIDS positive
    • 40 Pediatric
    • 15 HIV-O positive
    • 10 HIV-1/HIV-2 co-infected positive
    • 27 samples from pregnant females with HIV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727932


Locations
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United States, North Carolina
Avioq Inc
Research Triangle Park, North Carolina, United States, 27712
Sponsors and Collaborators
Avioq, Inc.
Clinical Reference Laboratory
Duke Clinical Research Institute
University of North Carolina

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Responsible Party: Avioq, Inc.
ClinicalTrials.gov Identifier: NCT03727932     History of Changes
Other Study ID Numbers: 100004
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases