Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection
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.
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
- Enrollment
- 2,500 participants
Conditions and interventions
Conditions
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
- Jun 30, 2007
- Primary completion
- Nov 19, 2007
- Completion
- Nov 19, 2007
- Last update posted
- Jan 26, 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 26, 2021 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00514605 live on ClinicalTrials.gov.