Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514605
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2007-08-08
Brief Title:
Testing of INSTI HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection
Sponsor:
bioLytical Laboratories
Organization:
bioLytical Laboratories
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The primary objective is to determine if INSTI performed with finger-stick whole blood venous whole blood and plasma demonstrates at least 980 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 ie 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 2500 subjects will participate in the study including 1500 subjects with unknown HIV status and 1000 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
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 ie 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 2500 subjects will participate in the study including 1500 subjects with unknown HIV status and 1000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None