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

NCT00514605 | Completed Phase 2

• 1 other identifier: 2007-01
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 14

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.

Conditions

HIV Infections

Keywords

HIV 1; AIDS; Assay; Rapid Test; HIV-1; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The percentage of INSTI™ results that agree between finger-stick whole blood, venous whole blood, and plasma.

  < 1 week

Interventions

Behavioral counseling OTHER

Standard-of-Care counseling at the Point-of-Care.

HIV-1 Antibody Test Kit DEVICE

Assay to detect HIV antibodies

Also known as: INSTI™ HIV-1 Antibody Test Kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• bioLytical Laboratories: lead

Study Sites (14)

LA County STD Program

Los Angeles, California, 90007, United States

Location

Michael Sumero, MD

Palm Springs, California, 92262, United States

Location

UCSD Antiviral Research Center

San Diego, California, 92103, United States

Location

Denver Public Health

Denver, Colorado, 80204, United States

Location

Midland Medical

Fort Lauderdale, Florida, 33306, United States

Location

University of Maryland, Baltimore School of Medicine

Baltimore, Maryland, 21201, United States

Location

Department of Epidemiology, Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Crossroads Clinic

Jackson, Mississippi, 39216, United States

Location

National Development and Research Institute

New York, New York, 10010, United States

Location

New York Academy of Medicine

New York, New York, 10029, United States

Location

Mazzoni Center

Philadelphia, Pennsylvania, 19107, United States

Location

AIDS/HIV Services Group

Charlottesville, Virginia, 22902, United States

Location

Richmond AIDS Consortium

Richmond, Virginia, 23219, United States

Location

Cross Over Ministry

Richmond, Virginia, 23224, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 10, 2007
• Study Start: July 1, 2007
• Primary Completion: November 20, 2007
• Study Completion: November 20, 2007
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (14)