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Completed Phase 2Phase 3 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT00514605

Public ClinicalTrials.gov record NCT00514605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00514605
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
bioLytical Laboratories
Industry
Enrollment
2,500 participants

Conditions and interventions

Conditions

Interventions

Other · Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2007 (Type not available)
Primary completion
Nov 20, 2007 (Actual)
Completion
Nov 20, 2007 (Actual)
Last update posted
Jan 27, 2021

2007

United States locations

U.S. sites
14
U.S. states
8
U.S. cities
11
Facility City State ZIP Site status
LA County STD Program Los Angeles California 90007 —
Michael Sumero, MD Palm Springs California 92262 —
UCSD Antiviral Research Center San Diego California 92103 —
Denver Public Health Denver Colorado 80204 —
Midland Medical Fort Lauderdale Florida 33306 —
University of Maryland, Baltimore School of Medicine Baltimore Maryland 21201 —
Department of Epidemiology, Johns Hopkins School of Public Health Baltimore Maryland 21205 —
Crossroads Clinic Jackson Mississippi 39216 —
National Development and Research Institute New York New York 10010 —
New York Academy of Medicine New York New York 10029 —
Mazzoni Center Philadelphia Pennsylvania 19107 —
AIDS/HIV Services Group Charlottesville Virginia 22902 —
Richmond AIDS Consortium Richmond Virginia 23219 —
Cross Over Ministry Richmond Virginia 23224 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00514605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 27, 2021 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00514605 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →