Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection

January 26, 2021 updated by: bioLytical Laboratories

A Study to Evaluate the Point-of-Care Use and Laboratory Investigational Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection

Each year up to 22 million persons in the US are tested for HIV. Currently available "rapid" tests do not provide test results for at least 30 minutes from the collection of serum and plasma from the subject. Providing accurate test results in less than a minute would make it easier to make timely decisions about treatment and counselling.

This study will compare results of an experimental rapid test to existing standards to determine if the test can reliably and accurately diagnose HIV in less than one minute.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to determine if INSTI™ performed with finger-stick whole blood, venous whole blood, and plasma demonstrates at least 98.0% sensitivity and specificity compared to an FDA-approved HIV testing algorithm.

The study will have two parts. The first part of the study will be conducted in institutions where HIV testing is routinely performed and where HIV counseling is offered [i.e. point of care (POC) centers]. The second part of the study will be conducted in a central laboratory that routinely conducts laboratory-based HIV testing using an FDA-licensed HIV-1 ELISA and Western blot test.

Geographically diverse POCs will be selected in the USA. Approximately 15-20 POCs are planned. Approximately 2,500 subjects will participate in the study including 1,500 subjects with unknown HIV status and 1,000 seropositive subjects. Across these POC sites, voluntary testing of 1500 subjects with unknown HIV status is planned with at least 500 of these subjects being high risk. Samples will be obtained from consenting subjects in the voluntary testing population including high-risk and known HIV 1 seropositive individuals.

Each subject is to receive an INSTI™ on finger-stick blood and parallel HIV testing of EDTA-treated venous whole blood and plasma samples will be conducted at a central laboratory.

The results of INSTI™ will not be given to the subject. The subject will be given the results of the POC HIV test only, per their standard of care procedures. Subsequent subject care decisions will NOT be based on the results of INSTI™.

Study Type

Interventional

Enrollment (Anticipated)

2500

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90007
        • LA County STD Program
      • Palm Springs, California, United States, 92262
        • Michael Sumero, MD
      • San Diego, California, United States, 92103
        • UCSD Antiviral Research Center
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Public Health
    • Florida
      • Fort Lauderdale, Florida, United States, 33306
        • Midland Medical
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore School of Medicine
      • Baltimore, Maryland, United States, 21205
        • Department of Epidemiology, Johns Hopkins School of Public Health
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Crossroads Clinic
    • New York
      • New York, New York, United States, 10010
        • National Development and Research Institute
      • New York, New York, United States, 10029
        • New York Academy of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mazzoni Center
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • AIDS/HIV Services Group
      • Richmond, Virginia, United States, 23219
        • Richmond AIDS Consortium
      • Richmond, Virginia, United States, 23224
        • Cross Over Ministry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unknown HIV status who are undergoing voluntary testing for HIV infection in a POC clinic setting or known HIV seropositive subjects willing to be re-tested.
  • Ability to give proper informed consent, or have legal parent or guardian provide consent.
  • Willingness to participate in a POC standard of care HIV counseling and testing program and receive POC standard of care test results
  • Willingness to provide the necessary volume of whole blood collected through venous blood draw and finger stick (approximately 10 ml)

Exclusion Criteria:

  • Subject self-report of history of multiple myeloma
  • Subject self-report of history of long-term anti-retroviral therapy with known low or non-existent antibody titre (sero-inversion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
INSTI™ performed with finger-stick whole blood, venous whole blood, and plasma demonstrates at least 98.0% sensitivity and specificity compared to an FDA-approved HIV testing algorithm
Time Frame: <1 week
<1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of INSTI™ results that agree between finger-stick whole blood, venous whole blood, and plasma.
Time Frame: < 1 week
< 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

bioLytical Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

November 20, 2007

Study Completion (Actual)

November 20, 2007

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 9, 2007

First Posted (Estimate)

August 10, 2007

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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