NCT03727932

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
757

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
Last Updated

November 2, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

October 25, 2018

Last Update Submit

November 1, 2018

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Clinical specificity and sensitivity of HIV Infection

    Clinical Specificity and 95% CI of the Profile Assay Clinical Sensitivity and 95% CI of the Profile Assay

    9 months

Study Arms (1)

VioOne HIV Profile

OTHER

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

Interventions

VioOne HIV Profile Supplemental AssayDEVICE

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.

VioOne HIV Profile

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • HIV positive,
  • HIV-2 positive
  • AIDS positive
  • Pediatric
  • HIV-O positive
  • HIV-1/HIV-2 co-infected positive
  • samples from pregnant females with HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avioq Inc

Research Triangle Park, North Carolina, 27712, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

November 1, 2018

Study Start

January 3, 2018

Primary Completion

April 11, 2018

Study Completion

April 11, 2018

Last Updated

November 2, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)