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

Completed · Phase 2/Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00514605

Run by

bioLytical Laboratories

People needed

2500

Starts

2007-07-01

Expected to finish

2007-11-20

Last updated by the study team

2021-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.