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

This study has been completed.
Sponsor:
Information provided by:
bioLytical Laboratories
ClinicalTrials.gov Identifier:
NCT00514605
First received: August 8, 2007
Last updated: December 10, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
HIV Infections
Other: Behavioral counseling
Device: HIV-1 Antibody Test Kit
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by bioLytical Laboratories:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 2500
Study Start Date: July 2007
Intervention Details:
    Other: Behavioral counseling
    Standard-of-Care counseling at the Point-of-Care.
    Device: HIV-1 Antibody Test Kit
    Assay to detect HIV antibodies
    Other Name: INSTI™ HIV-1 Antibody Test Kit
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™.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514605

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

No publications provided

Responsible Party: Rick Galli, Biolytical Laboratories
ClinicalTrials.gov Identifier: NCT00514605     History of Changes
Other Study ID Numbers: 2007-01
Study First Received: August 8, 2007
Last Updated: December 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by bioLytical Laboratories:
HIV 1
AIDS
Assay
Rapid Test
HIV-1
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014