Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay
Public ClinicalTrials.gov record NCT02026752. 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
Collection of Plasma Samples From Human Immunodeficiency Virus (HIV) Type 1 (HIV-1) Infected Individuals for the Clinical Evaluation of the Aptima HIV-1 Quant Dx Assay
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1) infected individuals that have viral loads across the dynamic range of the Aptima HIV-1 assay. The plasma samples will be tested in a method comparison study to support the approval of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of the method comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by comparing the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc., Branchburg, New Jersey) in plasma samples that have viral loads across the dynamic range of the Aptima HIV-1 assay.
Study identification
- NCT ID
- NCT02026752
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 468 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 15 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2013
- Primary completion
- Jan 31, 2015
- Completion
- Dec 31, 2016
- Last update posted
- Feb 22, 2017
2014 – 2017
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Palmtree Clinical Research Inc | Palm Springs | California | 92262 | — |
| UCSD - AnitViral Research Center (AVRC) | San Diego | California | 92103 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| University of Miami - AIDS Clinical Research Unit | Miami | Florida | 33136 | — |
| Community AIDS Network | Sarasota | Florida | 34237 | — |
| Wishard Health Services | Indianapolis | Indiana | 46202 | — |
| Louisiana State University | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
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 NCT02026752, 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 Feb 22, 2017 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02026752 live on ClinicalTrials.gov.