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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514605
• Other study ID #: 2007-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2007
• Est. completion date: November 20, 2007

Study information

• Verified date: January 2021
• Source: bioLytical Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: November 20, 2007
• Est. primary completion date: November 20, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

Other:
• Behavioral counseling
Standard-of-Care counseling at the Point-of-Care.

Device:
• HIV-1 Antibody Test Kit
Assay to detect HIV antibodies

Locations

Country	Name	City	State
United States	Department of Epidemiology, Johns Hopkins School of Public Health	Baltimore	Maryland
United States	University of Maryland, Baltimore School of Medicine	Baltimore	Maryland
United States	AIDS/HIV Services Group	Charlottesville	Virginia
United States	Denver Public Health	Denver	Colorado
United States	Midland Medical	Fort Lauderdale	Florida
United States	Crossroads Clinic	Jackson	Mississippi
United States	LA County STD Program	Los Angeles	California
United States	National Development and Research Institute	New York	New York
United States	New York Academy of Medicine	New York	New York
United States	Michael Sumero, MD	Palm Springs	California
United States	Mazzoni Center	Philadelphia	Pennsylvania
United States	Cross Over Ministry	Richmond	Virginia
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	UCSD Antiviral Research Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
bioLytical Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		<1 week
Secondary	The percentage of INSTI™ results that agree between finger-stick whole blood, venous whole blood, and plasma.		< 1 week